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.
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])
Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
Sequential
agenT-797
DrugagenT-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.
Number Of Participants With Treatment-related Adverse Events
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Number Of Dose-limiting Toxicities
Incidence of grade II-IV acute graft-versus-host disease (aGVHD)
Incidence of severe grade III-IV aGVHD
Progression-free Survival (PFS)
1-year PFS is the percentage of patients who are alive and whose cancer has not progressed within one year after receiving agenT-797.
Non-relapse Mortalilty (NRM)
NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT.
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This trial is not recruiting at the moment. You can still explore other options:
