Allogeneic iNKT Cell Therapy (agenT-797) After SCT

NCT07758218 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 2026-0983UWMSN | SMPH | DOM HematologyUW26004Protocol Version 6/10/26
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline through Day 29 post cell infusion

• Number Of Dose-limiting Toxicities

  Baseline through Day 29 post cell infusion

Secondary Outcomes (15)

• Incidence of grade II-IV acute graft-versus-host disease (aGVHD)

  Baseline through Day 29 post cell infusion

• Incidence of severe grade III-IV aGVHD

  Baseline through Day 29 post cell infusion

• Progression-free Survival (PFS)

  12 months

• Non-relapse Mortalilty (NRM)

  12 months

• Relapse-free Survival (RFS)

  12 months

Study Arms (1)

Allogeneic iNKT Cells

EXPERIMENTAL

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

Drug: agenT-797

Interventions

agenT-797 DRUG

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.

Allogeneic iNKT Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongtau Liu, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongtau Liu, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)