Recruiting
Phase 1

agenT-797

Sponsor:

University of Wisconsin, Madison

Code:

NCT07758218

Conditions

Allogenic Stem Cell Transplantation

Myeloid Malignancies

Lymphoid Malignancies

Acute Myeloid Leukemia

Chronic Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

agenT-797

Study Details

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.

Conditions

Allogenic Stem Cell Transplantation

Myeloid Malignancies

Lymphoid Malignancies

Acute Myeloid Leukemia

Chronic Myeloid Leukemia

Study ID

NCT07758218

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Allogeneic iNKT Cells

3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks.

Interventions

agenT-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.

Primary outcome measure

  • Number Of Participants With Treatment-related Adverse Events [ Time Frame: Baseline through Day 29 post cell infusion ]
  • Number Of Dose-limiting Toxicities [ Time Frame: Baseline through Day 29 post cell infusion ]

Central Contacts and Locations

Central contacts

Hongtau Liu, MD, PhD

608-263-6002clinicaltrials@cancer.wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.