Acute Myeloid Leukemia, Allogenic Stem Cell Transplantation, Chronic Myeloid Leukemia, Lymphoid Malignancies, Myelodysplastic Syndrome, Myeloid Malignancies
Conditions
Brief summary
The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are: * Is agenT-797 safe to use? * What medical problems do participants have when taking agenT-797? Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
Detailed description
This study is being done to assess the safety and determine the maximum tolerated dose (MTD) of allogeneic invariant natural killer T (iNKT) cell therapy (agenT-797) in patients undergoing allogeneic hematological SCT.
Interventions
DRUGagenT-797
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years at the time of consent * Adult patients anticipated to get an allogeneic hematopoietic cell transplantation (allo-SCT) * All donor types are accepted (MMUD \[mismatched unrelated donor\], MUD \[matched unrelated donor\], MSD \[matched sibling donor\], haploidentical) * All conditioning regimens will be accepted (MAC \[myeloablative conditioning\], RIC \[reduced-intensity conditioning\], NMAC \[non-myeloablative conditioning\]) * Karnofsky Performance Scale (KPS) \> 70 * Eligible Diagnoses: * Acute myeloid leukemia (AML) with intermediate/high-risk features or relapsed disease * Chronic myeloid leukemia (CML) in accelerated or blast phases * Myelodysplastic syndrome (MDS) with intermediate/high-risk features * Acute lymphoblastic leukemia (ALL) with high-risk features or relapsed disease * or any patients undergoing allogeneic stem cell transplant (allo-SCT) as standard of care could be eligible
Exclusion criteria
* Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of Participants With Treatment-related Adverse Events | Baseline through Day 29 post cell infusion | This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. |
| Number Of Dose-limiting Toxicities | Baseline through Day 29 post cell infusion | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free Survival (RFS) | 12 months | RFS is the length of time from agenT-797 administration until disease relapse or death. |
| Overall survival (OS) | 12 months | OS is the time from agenT-797 administration until death due to any cause. |
| Immune reconstitution based on lymphocyte subset panel | 12 months | — |
| Immunoglobulin levels | 12 months | Immune reconstitution measured through quantitative immunoglobulin levels |
| Incidence of treatment-emergent adverse event (TEAE) infection | Baseline to 29 days post cell infusion | — |
| Type of infection | Baseline to 29 days post cell infusion | Description of type of infection, e.g., bacterial, viral, or fungal. |
| Donor Chimerism | Baseline to 29 days post cell infusion | Donor chimerism will be assessed and categorized as full/complete chimerism (DNA ≥ 95% donor in CD3+ compartment) or mixed chimerism (DNA \< 95% donor in CD3+ compartment). |
| Absolute neutrophil count (ANC) | Baseline to 29 days post cell infusion | — |
| Non-relapse mortality rate (NRM) | 100 days | NRM is percentage of participants who died without recurrent or progressive disease within 100 days after allo-SCT. |
| Relapse rate | 100 days | Relapse rate is percentage of participants who relapsed within 100 days after allo-SCT |
| GVHD incidence | 100 days | GVHD incidence rate at day 100 post SCT is the percentage of participants who experienced GVHD within 100 days after allo-SCT |
| Incidence of grade II-IV acute graft-versus-host disease (aGVHD) | Baseline through Day 29 post cell infusion | — |
| Progression-free Survival (PFS) | 12 months | 1-year PFS is the percentage of patients who are alive and whose cancer has not progressed within one year after receiving agenT-797. |
| Incidence of severe grade III-IV aGVHD | Baseline through Day 29 post cell infusion | — |
| Non-relapse Mortalilty (NRM) | 12 months | NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT. |
Countries
United States
Contacts
CONTACTHongtau Liu, MD, PhD
PRINCIPAL_INVESTIGATORHongtau Liu, MD, PhD
University of Wisconsin, Madison
Outcome results
None listed