UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)
University of Wisconsin, Madison
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 featur…
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.
Location
- University of Wisconsin - MadisonMadison, Wisconsin