Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
Conditions
Keywords
Drug Therapy, Chimeric antigen receptor, Natural killer cells, Cell therapy, Allogeneic
Brief summary
This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL. Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
Detailed description
The product being tested in this study is called TAK-007. TAK-007 is being tested to evaluate the safety and tolerability in adult participants with r/r B-cell NHL. The study will include 2 parts: Part 1 (Dose escalation and dose expansion) and Part 2. In Part 1, dose escalation cohorts' participants will receive TAK-007 as follows: Part 1 dose escalation: * Part 1: Dose escalation: TAK-007 - 200×10\^6 CD19-CAR+ Viable NK (Natural Killer) Cells (±30%) * Part 1: Dose escalation: TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells (±25%) In Part 1 dose expansion phase, separate expansion cohorts for LBCL and iNHL (Cohorts 1A \[LBCL 3L+\] and 2A \[iNHL 3L+\]) and two additional dose expansion cohorts with a multi-dose regimen will be added (i.e., Cohort 1B and 1C) to evaluate more than 1 doses of TAK-007 after a 3-day regimen of lymphodepleting chemotherapy. Part 1 dose expansion cohorts' participants will receive TAK-007 as follows: * Part 1: Dose expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. * Part 1: Dose expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10\^6 CD19-CAR+ Viable NK Cells on Day 0 of the study. Based on the data in Part 1, a single TAK-007 dose level will be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D). Once RP2D is determined, participants will be enrolled in Part 2 of the study in the following cohorts: * Cohort 1: TAK-007 (LBCL) * Cohort 2: TAK-007 (iNHL) This multi-center trial will be conducted worldwide. Part 1 of the study will be conducted in the US, and Part 2 will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic and will enroll in a separate, long-term, follow-up study for continued safety assessments for up to 15 years after TAK-007 administration.
Interventions
BIOLOGICALTAK-007
TAK-007 intravenous injection.
Fludarabine and cyclophosphamide as per standard of care.
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study has 2 Parts: Part 1 is composed of dose escalation followed by dose expansion and Part 2.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who have a life expectancy ≥12 weeks. 2. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing disease of the following types: a. LBCL, including the following subtypes defined by the World Health Organization (WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii. High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii. HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular lymphoma (FL) or marginal zone lymphoma (MZL). v. T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii. Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix. Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal, extranodal, and splenic). 4. Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography (PET) -positive disease per the Lugano classification. 5. Participants who have r/r LBCL or r/r iNHL after ≥2 prior lines of systemic therapy: (Expansion Cohorts 1A and 1B \[LBCL 3L+\], and 2A \[iNHL 3L +\]) or r/r LBCL after 1 prior line of systemic therapy (Expansion Cohort 1C \[LBCL 2L\]): 1. Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody (mAb) and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT). 2. Participants with iNHL must have received an anti-CD20 mAb and an alkylating agent (eg, bendamustine or cyclophosphamide). 3. Preinduction salvage chemotherapy and ASCT should be considered 1 line of therapy. 4. Any consolidation/maintenance therapy after a chemotherapy regimen (without intervening relapse) should be considered 1 line of therapy with the preceding combination therapy. Maintenance antibody therapy should not be considered a line of therapy. 5. Single-agent anti-CD20 mAb therapy should not be considered a line of therapy. 6. Bridging chemotherapy given just prior to CAR-T cell therapy treatment should be considered one line of therapy together with cell therapy. 7. Participants who have received prior CD19-targeting CAR-T cell therapy must have achieved at least a partial response to the most recent CD19-targeting CAR-T cell therapy. 8. Participants with 1 prior line of therapy in Part 1 Cohort 1C must have either: * refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy OR * relapsed or refractory disease and be ineligible for intensive chemoimmunotherapy and/or high-dose chemotherapy followed by ASCT due to comorbidities and/or age. 6. Participants who have adequate bone marrow function defined as follows: 1. Absolute neutrophil count \>500/μL. 2. Platelet count of \>50,000/μL at screening. Participants with transfusion-dependent thrombocytopenia are excluded. 7. Participants who have adequate renal, hepatic, cardiac, and pulmonary function as defined in the study protocol: 1. Estimated glomerular filtration rate (GFR; Modification of Diet in Renal Disease equation \[MDRD\]) ≥30 mL/min. 2. Serum alanine aminotransferase/aspartate aminotransferase ≤5 times the upper limit of normal range (ULN), as long as participant is asymptomatic. 3. Total bilirubin ≤2 mg/dL. Participants with Gilbert's syndrome may have a bilirubin level \>2 × ULN, per discussion between the investigator and the medical monitor. 4. Left ventricular ejection fraction (LVEF) ≥40% as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month of determination of eligibility. 5. No evidence of clinically relevant pericardial effusion, and no acute clinically significant electrocardiogram (ECG) findings. 6. Absence of Grade ≥2 pleural effusion. Grade 1 stable pleural effusions are allowed. 7. Baseline oxygen saturation \>92% on room air. 8. Participants are required to consent to provide either sufficient archived formalin-fixed paraffin embedded (at least 10 unstained slides, ideally 20 unstained slides) or fresh tumor tissue obtained after the last relapse (see laboratory manual for details). Exception may be granted by sponsor medical monitor per discussion with investigator.
Exclusion criteria
1. Participants with total body weight of \<40 kg. 2. Participants with primary or secondary central nervous system (CNS) involvement by lymphoma. Participants with a history of secondary CNS involvement by lymphoma without evidence of CNS involvement at screening may be included. 3. Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma, or transformation from CLL/small lymphocytic lymphoma (Richter transformation). 4. Participants with a history of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed gastric cancer) or unless disease free for ≥3 years at screening. 5. Participants who have undergone autologous or allogeneic transplant or Chimeric antigen receptor T cells (CAR-T) or Chimeric antigen receptor Natural Killer cells (CAR-NK) therapy within 3 months of planned enrollment. Participants after allogeneic transplant have to be off systemic immunosuppressive therapy and without the evidence of clinically relevant acute or chronic graft-versus-host disease (GvHD) at the time of enrollment. 6. Treatment with any investigational products or any systemic anticancer treatment within 14 days or 2 half-lives of the treatment (whichever is longer) before conditioning therapy. For rituximab, a half-life of 22 days should be considered. 7. Participants with active infection, including fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management within 3 days before enrollment. 8. Participants with a history or presence of active or clinically relevant CNS disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, severe dementia, cerebellar disease, or any autoimmune disease with CNS involvement. For CNS disorders that recover or are in remission, participants without recurrence within 2 years of planned study enrollment may be included. 9. Participants with any of the following within 6 months of enrollment: myocardial infarction, cardiac angioplasty or stenting, unstable angina, symptomatic congestive heart failure (ie, New York Heart Association Class II or greater), clinically significant arrythmia (including uncontrolled atrial fibrillation), or any other clinically significant cardiac disease. 10. Participants who have received a live vaccine ≤6 weeks before the start of the conditioning regime.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 24 months | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. |
| Number of Participants With Clinically Significant Changes in Laboratory Parameters | Up to 24 months | Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests. |
| Number of Participants With Notable Changes in Vital Signs | Up to 24 months | Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute \[bpm\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR Per Investigator | Up to 24 months | ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration. CR is defined as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease. PR is defined as ≥50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites; absent/normal, regressed, but no increase in nonmeasured lesion; Spleen must have regressed by \>50% in length beyond normal. |
| Complete Response (CR) Per Investigator | Up to 24 months | CR is defined per Lugano 2014 criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease. |
| Duration of Response (DOR) Per Investigator | Up to 24 months | DOR is defined only for participants who experienced objective response (complete response or partial response) and is the time from the date of first documented objective response to the date of first documented disease progression or death, whichever comes first. Participants not meeting the criteria for progression or death will be censored at the last disease assessment. |
| Progression-free Survival (PFS) Per Investigator | Up to 24 months | Progression-free survival is defined as the time from TAK-007 administration to the date of disease progression or death from any cause, whichever comes first. Participants who do not have disease progression or die were censored at the last disease assessment. Participants who do not have postbaseline disease assessment prior to new anticancer therapy (excluding SCT) in the absence of death were censored at the dosing date of TAK-007. |
| Overall Survival (OS) | Up to 24 months | OS is defined as the time from TAK-007 administration to the date of death. Participants who did not die were censored at the last contact date. |
| Cmax - Maximum Observed Blood Concentration of TAK-007 | At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24 | The unit of measure 'copies per microgram' indicates copies of TAK-007 transgene per micrograms of genomic deoxyribonucleic acid (DNA). |
| Tmax - Time of First Occurrence of Cmax of TAK-007 | At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24 | — |
| Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007 | At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24 | — |
| AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007 | At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24 | The unit of measure 'day\*copies/µg' indicates day\*copies of TAK-007 transgene per µg of genomic DNA. |
| Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | Baseline, pre-dose (Day 0) and post-dose at Days 1, 7, 14, 21, 28 and Months 2,3,4,6,9,12 | Concentration of IL-15 and soluble immune factors (eg, Interferon (IFN)-gamma (γ) and IL-6) in plasma over time were reported. |
| Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Days -5, -4, 0 and post-dose at Days 0, 7, 28 and Months 2, 3, 4, 6, 9, 12 | B-cell aplasia is defined as \<50 B-cells per microliters (µl) of blood. |
| Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Up to 12 months | — |
| Percentage of Participants With Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Up to 60 months | — |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Takeda
Participant flow
Recruitment details
Participants took part in the investigative sites in the United States (US) from 12 November 2021 to 01 July 2024 (data cut off). The study is ongoing.
Pre-assignment details
Participants with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL), including large B-cell lymphoma (LBCL) participants who have failed ≥2 prior systemic therapies (i.e., third or higher line \[3L+\] treatment) and indolent non-Hodgkin lymphoma (iNHL) participants who have failed ≥2 prior systemic therapies (3L+) were included in this study. Part 2 will no longer be initiated and conducted as per the latest protocol amendment for this study.
Participants by arm
| Arm | Count |
|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0. | 3 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0. | 6 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D. | 11 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D. | 7 |
| Total | 27 |
Baseline characteristics
| Characteristic | Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 5.29 | 61.5 years STANDARD_DEVIATION 9.01 | 63.2 years STANDARD_DEVIATION 10.87 | 66.6 years STANDARD_DEVIATION 10.58 | 63.7 years STANDARD_DEVIATION 9.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 10 Participants | 6 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 8 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 9 Participants | 3 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 3 / 6 | 5 / 10 | 0 / 7 |
| other Total, other adverse events | 3 / 3 | 6 / 6 | 10 / 10 | 7 / 7 |
| serious Total, serious adverse events | 3 / 3 | 4 / 6 | 8 / 10 | 5 / 7 |
Outcome results
Primary
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Time frame: Up to 24 months
Population: Safety Analysis Set included all participants who received TAK-007 administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Bilirubin | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Aspartate aminotransferase (AST) | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Platelets | 2 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Immunoglobulin G | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Albumin | 1 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Alanine aminotransferase (ALT) | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Potassium | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Hemoglobin | 2 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Lymphocytes | 3 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Sodium | 1 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Estimated glomerular filtration rate (GFR) | 1 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Creatinine | 0 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Neutrophils | 3 Participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Leukocytes | 3 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Estimated glomerular filtration rate (GFR) | 2 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Hemoglobin | 5 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Leukocytes | 5 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Lymphocytes | 6 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Neutrophils | 6 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Platelets | 3 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Alanine aminotransferase (ALT) | 0 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Albumin | 3 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Aspartate aminotransferase (AST) | 0 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Bilirubin | 1 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Creatinine | 1 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Potassium | 0 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Sodium | 1 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Immunoglobulin G | 1 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Estimated glomerular filtration rate (GFR) | 3 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Sodium | 0 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Leukocytes | 10 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Neutrophils | 10 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Potassium | 1 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Hemoglobin | 7 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Creatinine | 2 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Aspartate aminotransferase (AST) | 1 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Alanine aminotransferase (ALT) | 1 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Lymphocytes | 7 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Platelets | 4 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Immunoglobulin G | 0 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Albumin | 2 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Bilirubin | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Albumin | 1 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Aspartate aminotransferase (AST) | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Sodium | 1 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Bilirubin | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Lymphocytes | 7 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Creatinine | 1 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Leukocytes | 7 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Estimated glomerular filtration rate (GFR) | 2 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Immunoglobulin G | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Potassium | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Platelets | 3 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Hemoglobin | 2 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Alanine aminotransferase (ALT) | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Clinically Significant Changes in Laboratory Parameters | Neutrophils | 7 Participants |
Primary
Number of Participants With Notable Changes in Vital Signs
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute \[bpm\]).
Time frame: Up to 24 months
Population: Safety Analysis Set included all participants who received TAK-007 administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Notable Changes in Vital Signs | 0 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Notable Changes in Vital Signs | 0 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Notable Changes in Vital Signs | 0 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Notable Changes in Vital Signs | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Time frame: Up to 24 months
Population: Safety Analysis Set included all participants who received TAK-007 administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 3 Participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 6 Participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 10 Participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
Secondary
AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007
The unit of measure 'day\*copies/µg' indicates day\*copies of TAK-007 transgene per µg of genomic DNA.
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Population: CK analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007 | 25.9 day*copies/µg | Standard Deviation 8.41 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007 | 1100 day*copies/µg | Standard Deviation 1130 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007 | 8330 day*copies/µg | Standard Deviation 12800 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007 | 825000 day*copies/µg | Standard Deviation 2240000 |
Secondary
Cmax - Maximum Observed Blood Concentration of TAK-007
The unit of measure 'copies per microgram' indicates copies of TAK-007 transgene per micrograms of genomic deoxyribonucleic acid (DNA).
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Population: Cellular kinetic (CK) analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Cmax - Maximum Observed Blood Concentration of TAK-007 | 1140 copies per microgram (µg) | Standard Deviation 299 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Cmax - Maximum Observed Blood Concentration of TAK-007 | 4730 copies per microgram (µg) | Standard Deviation 8500 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Cmax - Maximum Observed Blood Concentration of TAK-007 | 6540 copies per microgram (µg) | Standard Deviation 4510 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Cmax - Maximum Observed Blood Concentration of TAK-007 | 15800 copies per microgram (µg) | Standard Deviation 28500 |
Secondary
Complete Response (CR) Per Investigator
CR is defined per Lugano 2014 criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease.
Time frame: Up to 24 months
Population: mITT set included all participants who received TAK-007 administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Complete Response (CR) Per Investigator | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Complete Response (CR) Per Investigator | 33.3 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Complete Response (CR) Per Investigator | 20.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Complete Response (CR) Per Investigator | 57.1 percentage of participants |
Secondary
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time
Concentration of IL-15 and soluble immune factors (eg, Interferon (IFN)-gamma (γ) and IL-6) in plasma over time were reported.
Time frame: Baseline, pre-dose (Day 0) and post-dose at Days 1, 7, 14, 21, 28 and Months 2,3,4,6,9,12
Population: Pharmacodynamic Analysis Set included all participants from the safety analysis set who had a baseline and at least 1 postbaseline sample assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 28 | 6.843 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 28 | 10.618 picograms per milliter (pg/mL) | Standard Deviation 6.7349 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 1 | 81.089 picograms per milliter (pg/mL) | Standard Deviation 102.7746 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 7 | 9.236 picograms per milliter (pg/mL) | Standard Deviation 12.7713 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 14 | 10.342 picograms per milliter (pg/mL) | Standard Deviation 0.8935 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 21 | 7.915 picograms per milliter (pg/mL) | Standard Deviation 1.8965 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 7 | 18.288 picograms per milliter (pg/mL) | Standard Deviation 8.7229 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 14 | 15.190 picograms per milliter (pg/mL) | Standard Deviation 13.992 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Pre-dose | 33.737 picograms per milliter (pg/mL) | Standard Deviation 8.6072 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Pre-dose | 41.471 picograms per milliter (pg/mL) | Standard Deviation 39.3018 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Baseline | 31.558 picograms per milliter (pg/mL) | Standard Deviation 24.9063 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 21 | 3.984 picograms per milliter (pg/mL) | Standard Deviation 4.0063 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 14 | 12.037 picograms per milliter (pg/mL) | Standard Deviation 11.1691 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 7 | 56.935 picograms per milliter (pg/mL) | Standard Deviation 68.4453 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 21 | 14.645 picograms per milliter (pg/mL) | Standard Deviation 0.4215 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 28 | 6.569 picograms per milliter (pg/mL) | Standard Deviation 6.9839 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Baseline | 3.855 picograms per milliter (pg/mL) | Standard Deviation 1.0355 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 1 | 38.175 picograms per milliter (pg/mL) | Standard Deviation 12.2965 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Pre-dose | 4.814 picograms per milliter (pg/mL) | Standard Deviation 4.5419 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 1 | 8.993 picograms per milliter (pg/mL) | Standard Deviation 9.6177 |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Baseline | 4.289 picograms per milliter (pg/mL) | Standard Deviation 4.8094 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 1 | 17.015 picograms per milliter (pg/mL) | Standard Deviation 16.4689 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Baseline | 17.169 picograms per milliter (pg/mL) | Standard Deviation 17.2708 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 7 | 70.663 picograms per milliter (pg/mL) | Standard Deviation 106.7221 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 4 | 2.543 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Baseline | 22.738 picograms per milliter (pg/mL) | Standard Deviation 9.873 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 14 | 60.895 picograms per milliter (pg/mL) | Standard Deviation 68.6252 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 21 | 50.969 picograms per milliter (pg/mL) | Standard Deviation 60.5058 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Pre-dose | 35.890 picograms per milliter (pg/mL) | Standard Deviation 36.3154 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 28 | 12.127 picograms per milliter (pg/mL) | Standard Deviation 10.5958 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 28 | 39.678 picograms per milliter (pg/mL) | Standard Deviation 74.2068 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 2 | 8.975 picograms per milliter (pg/mL) | Standard Deviation 6.6271 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 2 | 5.774 picograms per milliter (pg/mL) | Standard Deviation 8.1652 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 6 | 2.667 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 3 | 0.000 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 4 | 0.000 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 7 | 44.602 picograms per milliter (pg/mL) | Standard Deviation 15.4926 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 21 | 7.734 picograms per milliter (pg/mL) | Standard Deviation 3.4047 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 6 | 0.000 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 1 | 51.992 picograms per milliter (pg/mL) | Standard Deviation 26.7839 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 14 | 9.384 picograms per milliter (pg/mL) | Standard Deviation 3.2634 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 7 | 18.364 picograms per milliter (pg/mL) | Standard Deviation 9.4926 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Baseline | 3.991 picograms per milliter (pg/mL) | Standard Deviation 1.6857 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 6 | 35.829 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Pre-dose | 56.035 picograms per milliter (pg/mL) | Standard Deviation 23.7989 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 21 | 57.785 picograms per milliter (pg/mL) | Standard Deviation 76.0284 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 14 | 70.825 picograms per milliter (pg/mL) | Standard Deviation 70.1581 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 28 | 36.489 picograms per milliter (pg/mL) | Standard Deviation 54.2244 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 2 | 29.038 picograms per milliter (pg/mL) | Standard Deviation 15.3845 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 3 | 2.669 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 3 | 10.806 picograms per milliter (pg/mL) | — |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Pre-dose | 14.454 picograms per milliter (pg/mL) | Standard Deviation 13.7658 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 1 | 50.657 picograms per milliter (pg/mL) | Standard Deviation 42.5779 |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 4 | 11.649 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Pre-dose | 34.547 picograms per milliter (pg/mL) | Standard Deviation 14.5419 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 3 | 4.149 picograms per milliter (pg/mL) | Standard Deviation 1.9754 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 1 | 26.694 picograms per milliter (pg/mL) | Standard Deviation 35.6445 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 14 | 28.009 picograms per milliter (pg/mL) | Standard Deviation 30.1577 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 21 | 86.566 picograms per milliter (pg/mL) | Standard Deviation 122.4368 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 28 | 35.749 picograms per milliter (pg/mL) | Standard Deviation 30.4532 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 2 | 27.540 picograms per milliter (pg/mL) | Standard Deviation 18.7882 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 3 | 11.565 picograms per milliter (pg/mL) | Standard Deviation 7.1666 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 1 | 2.295 picograms per milliter (pg/mL) | Standard Deviation 2.4267 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 7 | 3.169 picograms per milliter (pg/mL) | Standard Deviation 3.8668 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 14 | 3.460 picograms per milliter (pg/mL) | Standard Deviation 4.2615 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 21 | 4.365 picograms per milliter (pg/mL) | Standard Deviation 3.7982 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 28 | 4.413 picograms per milliter (pg/mL) | Standard Deviation 7.99 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 2 | 3.650 picograms per milliter (pg/mL) | Standard Deviation 2.8818 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 3 | 0.924 picograms per milliter (pg/mL) | Standard Deviation 1.6003 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 4 | 1.501 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 6 | 0.000 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Baseline | 5.059 picograms per milliter (pg/mL) | Standard Deviation 3.7114 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 1 | 31.473 picograms per milliter (pg/mL) | Standard Deviation 14.1248 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 7 | 15.775 picograms per milliter (pg/mL) | Standard Deviation 9.6798 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 14 | 13.592 picograms per milliter (pg/mL) | Standard Deviation 8.2004 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 21 | 9.900 picograms per milliter (pg/mL) | Standard Deviation 6.4358 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 28 | 5.200 picograms per milliter (pg/mL) | Standard Deviation 2.0747 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 2 | 4.242 picograms per milliter (pg/mL) | Standard Deviation 1.9915 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 4 | 3.820 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 6 | 2.575 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Baseline | 51.761 picograms per milliter (pg/mL) | Standard Deviation 120.7897 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Pre-dose | 24.548 picograms per milliter (pg/mL) | Standard Deviation 44.4643 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 7 | 31.201 picograms per milliter (pg/mL) | Standard Deviation 61.1626 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 4 | 13.138 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 6 | 8.848 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Baseline | 3.453 picograms per milliter (pg/mL) | Standard Deviation 3.1142 |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Pre-dose | 2.309 picograms per milliter (pg/mL) | Standard Deviation 2.0751 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 28 | 4.540 picograms per milliter (pg/mL) | Standard Deviation 2.6362 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 28 | 7.208 picograms per milliter (pg/mL) | Standard Deviation 16.5226 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 9 | 8.254 picograms per milliter (pg/mL) | Standard Deviation 3.8536 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 2 | 2.867 picograms per milliter (pg/mL) | Standard Deviation 0.5611 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 12 | 12.077 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 4 | 2.100 picograms per milliter (pg/mL) | Standard Deviation 0.0263 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 21 | 14.882 picograms per milliter (pg/mL) | Standard Deviation 36.1528 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 1 | 172.001 picograms per milliter (pg/mL) | Standard Deviation 347.045 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 6 | 2.039 picograms per milliter (pg/mL) | Standard Deviation 0.3939 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 9 | 2.685 picograms per milliter (pg/mL) | Standard Deviation 0.9093 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 12 | 2.613 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 14 | 16.038 picograms per milliter (pg/mL) | Standard Deviation 38.8392 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 7 | 19.255 picograms per milliter (pg/mL) | Standard Deviation 44.8587 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Month 3 | 2.409 picograms per milliter (pg/mL) | Standard Deviation 0.5595 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Baseline | 37.396 picograms per milliter (pg/mL) | Standard Deviation 52.8148 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Pre-dose | 6.776 picograms per milliter (pg/mL) | Standard Deviation 8.2117 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Pre-dose | 96.015 picograms per milliter (pg/mL) | Standard Deviation 150.1385 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Day 1 | 158.548 picograms per milliter (pg/mL) | Standard Deviation 406.9127 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 3 | 9.016 picograms per milliter (pg/mL) | Standard Deviation 5.579 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Baseline | 4.129 picograms per milliter (pg/mL) | Standard Deviation 7.7186 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 7 | 29.970 picograms per milliter (pg/mL) | Standard Deviation 20.1722 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 2 | 26.493 picograms per milliter (pg/mL) | Standard Deviation 28.8072 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 21 | 51.144 picograms per milliter (pg/mL) | Standard Deviation 46.2887 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 28 | 57.836 picograms per milliter (pg/mL) | Standard Deviation 34.8662 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 14 | 10.707 picograms per milliter (pg/mL) | Standard Deviation 3.8889 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 1 | 38.546 picograms per milliter (pg/mL) | Standard Deviation 26.68 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Baseline | 2.802 picograms per milliter (pg/mL) | Standard Deviation 1.0243 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 12 | 0.000 picograms per milliter (pg/mL) | — |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 4 | 11.405 picograms per milliter (pg/mL) | Standard Deviation 4.1568 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 7 | 13.434 picograms per milliter (pg/mL) | Standard Deviation 6.9273 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 9 | 0.000 picograms per milliter (pg/mL) | Standard Deviation 0 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 6 | 0.954 picograms per milliter (pg/mL) | Standard Deviation 0.8722 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Day 14 | 155.058 picograms per milliter (pg/mL) | Standard Deviation 233.9229 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 4 | 0.473 picograms per milliter (pg/mL) | Standard Deviation 0.945 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Pre-dose | 44.125 picograms per milliter (pg/mL) | Standard Deviation 29.8318 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-15: Day 21 | 6.176 picograms per milliter (pg/mL) | Standard Deviation 2.6925 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 3 | 1.489 picograms per milliter (pg/mL) | Standard Deviation 1.4878 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IL-6: Month 2 | 1.317 picograms per milliter (pg/mL) | Standard Deviation 1.3573 |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time | IFN-g: Month 6 | 15.160 picograms per milliter (pg/mL) | Standard Deviation 11.9336 |
Secondary
Duration of Response (DOR) Per Investigator
DOR is defined only for participants who experienced objective response (complete response or partial response) and is the time from the date of first documented objective response to the date of first documented disease progression or death, whichever comes first. Participants not meeting the criteria for progression or death will be censored at the last disease assessment.
Time frame: Up to 24 months
Population: mITT set included all participants who received TAK-007 administration. Overall number of participants analyzed is the number of participants with events.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Duration of Response (DOR) Per Investigator | 4.9 months |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Duration of Response (DOR) Per Investigator | 2.4 months |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Duration of Response (DOR) Per Investigator | 4.9 months |
Secondary
ORR Per Investigator
ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration. CR is defined as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease. PR is defined as ≥50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites; absent/normal, regressed, but no increase in nonmeasured lesion; Spleen must have regressed by \>50% in length beyond normal.
Time frame: Up to 24 months
Population: Modified Intent-to-Treat (mITT) set included all participants who received TAK-007 administration.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | ORR Per Investigator | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | ORR Per Investigator | 50.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | ORR Per Investigator | 50.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | ORR Per Investigator | 85.7 percentage of participants |
Secondary
Overall Survival (OS)
OS is defined as the time from TAK-007 administration to the date of death. Participants who did not die were censored at the last contact date.
Time frame: Up to 24 months
Population: mITT set included all participants who received TAK-007 administration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Overall Survival (OS) | 8.9 months |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Overall Survival (OS) | NA months |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Overall Survival (OS) | 8.4 months |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Overall Survival (OS) | NA months |
Secondary
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration
B-cell aplasia is defined as \<50 B-cells per microliters (µl) of blood.
Time frame: Pre-dose at Days -5, -4, 0 and post-dose at Days 0, 7, 28 and Months 2, 3, 4, 6, 9, 12
Population: Pharmacodynamic Analysis Set included all participants from the safety analysis set who had a baseline and at least 1 postbaseline sample assessment. Number analyzed is the number of participants with data available for analysis at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -4 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 7 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day 0 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at 1 hr (+/-15 mins) at Day 0 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 28 | 33.3 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -5 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -5 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 2 | 40.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -4 | 20.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day 0 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at 1 hr (+/-15 mins) at Day 0 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 7 | 80.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 28 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 3 | 20.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 4 | 20.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 6 | 20.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at 1 hr (+/-15 mins) at Day 0 | 90.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 7 | 80.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -5 | 70.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 28 | 80.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 2 | 50.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 6 | 10.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 3 | 20.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -4 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day 0 | 90.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 4 | 10.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day 0 | 57.1 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 2 | 71.4 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 6 | 42.9 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at 1 hr (+/-15 mins) at Day 0 | 85.7 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -5 | 71.4 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 4 | 28.6 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 12 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 7 | 57.1 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 3 | 71.4 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Month 9 | 14.3 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Pre-dose at Day -4 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration | Post-dose at Day 28 | 71.4 percentage of participants |
Secondary
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Time frame: Up to 12 months
Population: Safety Analysis Set included all participants who received TAK-007 administration. Number analyzed is the number of participants with data available for analysis at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 14 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 14 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Prevalence at Day -5 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Prevalence at Day -5 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 14 | 33.3 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Prevalence at Day -5 | 40.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 4 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 6 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 3 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 14 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 9 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 12 | 100 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 3 | 50.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Prevalence at Day -5 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 2 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 2 | 33.3 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 12 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 6 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 28 | 60.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 9 | 0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 4 | 50.0 percentage of participants |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Prevalence at Day -4 | 100 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Prevalence at Day -5 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 2 | 20.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 3 | 33.3 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 4 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 6 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 2 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 3 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Prevalence at Day -5 | 10.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 14 | 10.0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 14 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 4 | 0 percentage of participants |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 6 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 28 | 42.9 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 2 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 28 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 12 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Prevalence at Day -5 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 9 | 50.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 6 | 50.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 9 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Day 14 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 4 | 50.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 2 | 42.9 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 4 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Month 3 | 33.3 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 12 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Incidence at Day 14 | 42.9 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-HLA Antibodies: Prevalence at Day -5 | 50.0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 3 | 0 percentage of participants |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time | Anti-CAR Antibodies: Incidence at Month 6 | 0 percentage of participants |
Secondary
Percentage of Participants With Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Time frame: Up to 60 months
Secondary
Progression-free Survival (PFS) Per Investigator
Progression-free survival is defined as the time from TAK-007 administration to the date of disease progression or death from any cause, whichever comes first. Participants who do not have disease progression or die were censored at the last disease assessment. Participants who do not have postbaseline disease assessment prior to new anticancer therapy (excluding SCT) in the absence of death were censored at the dosing date of TAK-007.
Time frame: Up to 24 months
Population: mITT set included all participants who received TAK-007 administration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Progression-free Survival (PFS) Per Investigator | 0.95 months |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Progression-free Survival (PFS) Per Investigator | 2.23 months |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Progression-free Survival (PFS) Per Investigator | 2.00 months |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Progression-free Survival (PFS) Per Investigator | 5.62 months |
Secondary
Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Population: CK analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007 | 0.05 days |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007 | 5.39 days |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007 | 0.05 days |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007 | 6.87 days |
Secondary
Tmax - Time of First Occurrence of Cmax of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Population: CK analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Tmax - Time of First Occurrence of Cmax of TAK-007 | 0.05 days |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tmax - Time of First Occurrence of Cmax of TAK-007 | 0.31 days |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tmax - Time of First Occurrence of Cmax of TAK-007 | 0.04 days |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Tmax - Time of First Occurrence of Cmax of TAK-007 | 0.05 days |