Leukemia, Myeloid, Acute
Conditions
Brief summary
This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps stop the growth of cancer cells and stops the patient's immune system from rejecting the donor's natural killer cells. Modified natural killer cells may help the body build an immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white blood cells (including natural killer cells) to kill leukemia cells. In the phase II and pediatric portion of the study, the investigators intend to use maximal tolerated or tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to support the donor derived NK cells in vivo after adoptive transfer. With amendment 16, the decision was made to return to the use of rhIL-2 support instead of ALT-803.
Interventions
DRUGFludarabine
DRUGCyclophosphamide
PROCEDURELeukapheresis
BIOLOGICALCytokine-induced killer cells
BIOLOGICALIL-2
DRUGALT-803
PROCEDUREPeripheral blood for correlative studies
-Screening, Day 0 prior to CIML NK infusion, Day 1, Day 3, Day 7, Day 8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 60, Day 100, 6 months, 9 months, 12 months, and at disease relapse
PROCEDUREBone marrow for correlative studies
-Screening, Day 8, Day 14, Day 28, Between Day 42 and 60, Day 100, at disease relapse
Sponsors
American Society of Clinical Oncology
American Society of Hematology
Gabrielle's Angel Foundation
The Leukemia and Lymphoma Society
National Cancer Institute (NCI)
ImmunityBio, Inc.
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis requirement for phase I patients: * Refractory AML without complete remission (CR) after induction therapy (primary induction failure) or relapsed AML after obtaining a CR. * OR High-risk AML (by ELN criteria; See Appendix C) in complete remission (CR) and has either refused hematopoietic stem cell transplantation OR is currently not eligible for hematopoietic stem cell transplantation OR for whom hematopoietic stem cell transplantation is being reserved for later relapse. This is inclusive of patients with minimal residual disease evidenced by cytogenetics, molecular testing, and/or flow cytometry. * OR Myelodysplastic syndrome (MDS) with excess blasts (\>5%) and progressive disease at any time after initiation of DNA hypomethylator treatment during the past 2 years, OR failure to achieve complete or partial response or hematological improvement (see section 12.4) after at least six cycles of azacytidine or four cycles of decitabine administered during the past 2 years, OR intolerance to azacytidine or decitabine. MDS patients with isolated 5q- abnormalities that meet these criteria after lenalidomide therapy and DNA hypomethylator therapy are also eligible. * Diagnosis requirement for phase II patients: \*Refractory AML without CR after induction therapy (primary induction failure) or relapsed AML after obtaining a CR. Favorable-risk core binding factor (CBF) mutated AML and acute promyelocytic leukemia (APL) will be excluded. * Diagnosis requirement for pediatric cohort patients: \*Refractory AML without complete remission (CR) after induction therapy (primary induction failure) or relapsed AML after obtaining a CR. * Age requirement for phase I and phase II patients: At least 18 years of age. * Age requirement for pediatric cohort: 2-17 years of age. * Available HLA-haploidentical donor that meets the following criteria: * Related donor (parent, sibling, offspring, or offspring of sibling) * At least 18 years of age * HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus. * In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study. * Negative for hepatitis, HTLV, and HIV on donor viral screen * Not pregnant * Voluntary written consent to participate in this study * Patients with known CNS involvement with AML are eligible provided that they have been treated and CSF is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment. * Karnofsky/Lansky performance status ≥ 50 % * Adequate organ function as defined below: * Total bilirubin ≤ 2 mg/dL * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine within normal institutional limits OR creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault Formula (adults) or Schwartz formula (pediatric cohort) * Oxygen saturation ≥90% on room air * Ejection fraction ≥35% * Able to be off corticosteroids and any other immune suppressive medications beginning on Day -3 and continuing until 30 days after the infusion of the CIML NK cells. However, use of low-level corticosteroids is permitted if deemed medically necessary. Low-level corticosteroid use is defined as 10mg or less of prednisone (or equivalent for other steroids) per day. * Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the DLT evaluation period. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion criteria
* Relapsed after allogeneic transplantation. * Isolated extramedullary relapse (phase II only). * More than one course of salvage chemotherapy for primary induction failure or AML relapsing after CR1 (phase II only). * Circulating blast count ≥30,000/µL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed). * Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B or C infection. * Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities. * New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that have not been evaluated with bronchoscopy. Infiltrates attributed to infection must be stable/ improving after 1 week of appropriate therapy (4 weeks for presumed or proven fungal infections). * Known hypersensitivity to one or more of the study agents. * Received any investigational drugs within the 14 days prior to the first dose of fludarabine. * Pregnant and/or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I) | 35 days | Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose. |
| Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II) | Up to 3 years | * Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions * Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils \<1000 /μL or platelets \<100,000 /μL in the blood. |
| Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Through Day 100 | * Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment. * Adverse events will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC \< 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | Up to 3 years | DFS is defined as the time from the day CR, mCR, or CRi is documented until disease progression or death. |
| Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | 35 days | — |
| Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Through Day 100 | * Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment. * AEs will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC \< 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100. |
| Overall Survival (OS) (Phase I, Phase II, and Pediatric) | Up to 3 years | OS is defined from the date of first dose of fludarabine on this study until death. |
| Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | Up to 3 years | DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death. |
| Time to Progression (Phase I, Phase II, and Pediatric) | Up to 3 years | TTP is defined as the time from date of first dose of fludarabine until evidence of disease progression. |
Countries
United States
Participant flow
Recruitment details
* 2 patients enrolled in the Phase I portion of the trial relapsed and were re-enrolled as compassionate use patients and are only included in the enrollment numbers once. * With amendment 16, the decision was made to return to the use of rhIL-2 support instead of ALT-803.
Participants by arm
| Arm | Count |
|---|---|
| Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells * Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4.
* Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1.
* CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0.
* Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses) | 5 |
| Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells * Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4.
* Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1.
* CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0.
* Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses) | 5 |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells * Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4.
* Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors over 5 hours on day -1.
* CIML NK Cells: Patients undergo CIML NK cell infusion over 15-60 minutes on day 0.
* Interleukin-2: Patients receive aldesleukin SC every other day for 2 weeks starting on day 1 (total of 7 doses) | 9 |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells * Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4.
* Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1.
* CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0.
* Subcutaneous ALT-803 will begin approximately 4 hours after the infusion and will continue for a total of 2 doses (Days 0 and 5). | 8 |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells The recipient will begin a lymphodepleting preparative regimen of fludarabine and cyclophosphamide on Day -6. The haploidentical donor identified by HLA matching of the immediate family members will undergo non-mobilized large volume (20-L) leukapheresis on Day -1, and the NK cell product will be infused into the recipient on Day 0. Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses. | 9 |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells * Lymphodepleting Preparative Regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 2 hours on days -5 and -4.
* Donor Leukapheresis: Peripheral blood cells are collected from haploidentical related donors on Day -1
* CIML NK Cells: Patients undergo CIML NK cell infusion on Day 0
* Subcutaneous IL-2 will begin approximately 2-4 hours after infusion and will continue every other day through Day 12 for a total of 7 doses | 8 |
| Donors -The haploidentical donor identified by HLA matching of the immediate family members (parents, siblings, and children) will undergo non-mobilized leukapheresis on Day -1. Peripheral blood mononuclear cells (PBMCs) will be collected using standard collection techniques. | 45 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 1 | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells | Total | Donors | Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 76 years | 52 years | 46 years | 13 years | 71 years | 62.5 years | 71 years | 72 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 80 Participants | 38 Participants | 7 Participants | 9 Participants | 8 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 7 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 74 Participants | 36 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 89 participants | 45 participants | 8 participants | 9 participants | 8 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 38 Participants | 22 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 51 Participants | 23 Participants | 5 Participants | 6 Participants | 3 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 5 | 4 / 5 | 8 / 9 | 8 / 8 | 9 / 9 | 8 / 8 | 0 / 0 |
| other Total, other adverse events | 4 / 4 | 5 / 5 | 9 / 9 | 8 / 8 | 9 / 9 | 8 / 8 | 0 / 0 |
| serious Total, serious adverse events | 2 / 5 | 0 / 5 | 2 / 9 | 4 / 8 | 4 / 9 | 0 / 8 | 0 / 0 |
Outcome results
Primary
Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)
* Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions * Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils \<1000 /μL or platelets \<100,000 /μL in the blood.
Time frame: Up to 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I | Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II) | 3 Participants |
Primary
Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)
Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose.
Time frame: 35 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I | Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I) | 1.0 x 10^7 cells/kg |
Primary
Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)
* Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment. * Adverse events will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC \< 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100.
Time frame: Through Day 100
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hyperkalemia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Headache: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Chills : Grade 2 | 5 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Anorexia : Grade 2 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Anorexia : Grade 3 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Alanine aminotransferase increased : Grade 1 | 3 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Alanine aminotransferase increased : Grade 3 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Aspartate aminotransferase increased : Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Aspartate aminotransferase increased : Grade 3 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Fever : Grade 3 | 3 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypertension : Grade 2 | 2 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hyperammonemia : Grade 2 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Capillary leak syndrome : Grade 2 | 2 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypokalemia : Grade 1 | 2 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypophosphatemia : Grade 4 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypocalcemia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypomagnesemia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Headache: Grade 2 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Myalgia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Arthralgia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Fatigue: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Injection site reaction: Grade 2 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Epistaxis: Grade 3 | 3 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hematoma: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Paresthesia: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Pain: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Pain: Grade 2 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Sinus tachycardia: Grade 1 | 2 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Tachypnea: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Vomiting: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Skin induration: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Malaise: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Febrile neutropenia: Grade 1 | 3 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Flushing: Grade 1 | 1 Participants |
| Phase I | Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort) | Hypoalbuminemia: Grade 1 | 1 Participants |
Secondary
Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)
DFS is defined as the time from the day CR, mCR, or CRi is documented until disease progression or death.
Time frame: Up to 3 years
Population: Only those patients with CR, mCR, or CRi are evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | 126.00 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | 73.00 days |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | 56.00 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | 30.00 days |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric) | 60.00 days |
Secondary
Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)
DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death.
Time frame: Up to 3 years
Population: Only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | 126.0 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | 22.0 days |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | 76.5 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | 30.0 days |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Duration of Remission (DOR) (Phase I, Phase II, and Pediatric) | 80.0 days |
Secondary
Overall Survival (OS) (Phase I, Phase II, and Pediatric)
OS is defined from the date of first dose of fludarabine on this study until death.
Time frame: Up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 39.00 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 142.50 days |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 49.00 days |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 92.00 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 38.00 days |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Overall Survival (OS) (Phase I, Phase II, and Pediatric) | 147.00 days |
Secondary
Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric)
Time frame: 35 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 0 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 0 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 1 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 1 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 1 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 0 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 2 Participants |
| Phase I | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 3 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 2 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 6 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 3 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 0 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission with incomplete blood count recovery (CRi) | 1 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Progressive disease (PD) | 4 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Stable disease (SD) | 2 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Complete remission (CR) | 0 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Partial remission (PR) | 0 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Not evaluable | 1 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Treatment Failure (TF) | 0 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Marrow complete response (mCR) | 0 Participants |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Response Assessed According to IWG Criteria (Phase 1, Phase II, and Pediatric) | Morphologically leukemia-free state (MLFS) | 0 Participants |
Secondary
Time to Progression (Phase I, Phase II, and Pediatric)
TTP is defined as the time from date of first dose of fludarabine until evidence of disease progression.
Time frame: Up to 3 years
Population: Not evaluable: 2 patients Phase 1 Dose Level 1 (didn't receive adequate cell dose, expired before infusion). 2 patients Phase I Dose Level 2 (expired before infusion, received haplo transplant before PD). 3 patients Phase I Dose Level 3 (no bone marrow biopsy, 2-expired before PD). 2 patients Phase II IL-2 (2-no bone marrow biopsy). 1 patient Phase II ALT-803 (expired before response assessment). 2 patients Pediatric (expired before PD, poor bone marrow sample).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I | Time to Progression (Phase I, Phase II, and Pediatric) | 20.0 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Time to Progression (Phase I, Phase II, and Pediatric) | 36.0 days |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Time to Progression (Phase I, Phase II, and Pediatric) | 46.0 days |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Time to Progression (Phase I, Phase II, and Pediatric) | 34.0 days |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Time to Progression (Phase I, Phase II, and Pediatric) | 33.0 days |
| Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells | Time to Progression (Phase I, Phase II, and Pediatric) | 28.0 days |
Secondary
Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II)
* Graded using the National Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Related indicates possibly, probably, or definitely related to study treatment. * AEs will be collected from Day 0 to Day +35; however, bone marrow suppression (ANC \< 500/uL/µL) and AEs of GVHD involving the liver, skin, or GI tract will be recorded to Day 100.
Time frame: Through Day 100
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hematuria: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Capillary leak syndrome: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pleural effusion: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Insomnia: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Wheezing: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Encephalopathy: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Abdominal pain: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 2 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Bacteremia (strep mitis): Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rash maculo-papular: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alkaline phosphatase increased: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary alveolar hemorrhage: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sinus tachycardia: Grade 2 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 4 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Febrile neutropenia: Grade 3 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lung infection: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sepsis: Grade 4 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after IL-2 administration: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Weight loss: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoxia: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Dyspnea: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | White blood cell decreased: Grade 4 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lethargy: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Creatinine increased: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lymphocyte count decreased: Grade 4 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Chills: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Aspartate aminotransferase increased: Grade 1 | 1 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Neutrophil count decreased: Grade 4 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoalbuminemia: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after CIML NK cell infusion | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alopecia: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pruritus: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alanine aminotransferase increased: Grade 1 | 2 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Vomiting: Grade 1 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 3 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 2 | 0 Participants |
| Phase I | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Aspartate aminotransferase increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after IL-2 administration: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Capillary leak syndrome: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoxia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pleural effusion: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Dyspnea: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Insomnia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Wheezing: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoalbuminemia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Encephalopathy: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after CIML NK cell infusion | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pruritus: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Bacteremia (strep mitis): Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Abdominal pain: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Creatinine increased: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | White blood cell decreased: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rash maculo-papular: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alkaline phosphatase increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lethargy: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary alveolar hemorrhage: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alanine aminotransferase increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lymphocyte count decreased: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sinus tachycardia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alopecia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Vomiting: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Febrile neutropenia: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Chills: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Neutrophil count decreased: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lung infection: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hematuria: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Weight loss: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sepsis: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 1 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Aspartate aminotransferase increased: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alanine aminotransferase increased: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alkaline phosphatase increased: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sinus tachycardia: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Febrile neutropenia: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after IL-2 administration: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoxia: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Dyspnea: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lethargy: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Chills: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 1 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after CIML NK cell infusion | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alopecia: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 2 | 1 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Insomnia: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Encephalopathy: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Wheezing: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pleural effusion: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Capillary leak syndrome: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Vomiting: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Neutrophil count decreased: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lymphocyte count decreased: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | White blood cell decreased: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sepsis: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lung infection: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 4 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary alveolar hemorrhage: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rash maculo-papular: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Abdominal pain: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hematuria: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pruritus: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Creatinine increased: Grade 2 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Weight loss: Grade 1 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Bacteremia (strep mitis): Grade 3 | 0 Participants |
| Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoalbuminemia: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 1 | 2 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 3 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alanine aminotransferase increased: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 2 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Vomiting: Grade 1 | 5 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 1 | 5 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hematuria: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alopecia: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after CIML NK cell infusion | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 3 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 2 | 4 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Aspartate aminotransferase increased: Grade 1 | 2 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 3 | 5 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Chills: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pruritus: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Neutrophil count decreased: Grade 4 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lethargy: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lymphocyte count decreased: Grade 4 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 3 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | White blood cell decreased: Grade 4 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 1 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Dyspnea: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 1 | 4 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoxia: Grade 2 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Creatinine increased: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 1 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after IL-2 administration: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 3 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sepsis: Grade 4 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 1 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 1 | 2 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lung infection: Grade 3 | 4 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Febrile neutropenia: Grade 3 | 6 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 1 | 4 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sinus tachycardia: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Weight loss: Grade 1 | 2 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 4 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alkaline phosphatase increased: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary alveolar hemorrhage: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rash maculo-papular: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Abdominal pain: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 2 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoalbuminemia: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Encephalopathy: Grade 3 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Insomnia: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Wheezing: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 1 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 2 | 5 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Bacteremia (strep mitis): Grade 3 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pleural effusion: Grade 2 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 3 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 1 | 1 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 3 | 0 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 2 | 2 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 2 | 3 Participants |
| Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Capillary leak syndrome: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Capillary leak syndrome: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 3 | 3 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sepsis: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Malaise: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fever: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Encephalopathy: Grade 3 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Bacteremia (strep mitis): Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Insomnia: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Vomiting: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Fatigue: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 3 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lung infection: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Febrile neutropenia: Grade 3 | 6 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alopecia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hematuria: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoalbuminemia: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 2 | 3 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after CIML NK cell infusion | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Anorexia: Grade 2 | 3 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Aspartate aminotransferase increased: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Infusion related reaction: Grade 3 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Sinus tachycardia: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Wheezing: Grade 2 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Injection site reaction: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pleural effusion: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Platelet count decreased: Grade 4 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypertension: Grade 3 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Chills: Grade 2 | 3 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alkaline phosphatase increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Weight loss: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Neutrophil count decreased: Grade 4 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lethargy: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pruritus: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary alveolar hemorrhage: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Lymphocyte count decreased: Grade 4 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 3 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Diarrhea: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | White blood cell decreased: Grade 4 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Confusion: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Nausea: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypotension: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rash maculo-papular: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 1 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Dyspnea: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Blood bilirubin increased: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hyponatremia: Grade 3 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Alanine aminotransferase increased: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Mucositis oral: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Hypoxia: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Cytokine release syndrome: Grade 2 | 2 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Abdominal pain: Grade 1 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Proteinuria: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 1 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors after IL-2 administration: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Pulmonary edema: Grade 2 | 1 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Creatinine increased: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Rigors: Grade 2 | 0 Participants |
| Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells | Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II) | Headache: Grade 3 | 0 Participants |