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NCT Number: NCT07758218

Allogeneic iNKT Cell Therapy (agenT-797) After SCT

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.

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Key information

Conditions

Allogenic Stem Cell Transplantation Acute Myeloid Leukemia Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphoid Malignancies Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloid Malignancies Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number Of Participants With Treatment-related Adverse Events

    Time frame: 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.

  2. Number Of Dose-limiting Toxicities

    Time frame: Baseline through Day 29 post cell infusion

Secondary outcomes

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

    Time frame: Baseline through Day 29 post cell infusion

  2. Incidence of severe grade III-IV aGVHD

    Time frame: Baseline through Day 29 post cell infusion

  3. Progression-free Survival (PFS)

    Time frame: 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.

  4. Non-relapse Mortalilty (NRM)

    Time frame: 12 months

    NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT.

  5. Relapse-free Survival (RFS)

    Time frame: 12 months

    RFS is the length of time from agenT-797 administration until disease relapse or death.

  6. Overall survival (OS)

    Time frame: 12 months

    OS is the time from agenT-797 administration until death due to any cause.

  7. Immune reconstitution based on lymphocyte subset panel

    Time frame: 12 months

  8. Immunoglobulin levels

    Time frame: 12 months

    Immune reconstitution measured through quantitative immunoglobulin levels

  9. Incidence of treatment-emergent adverse event (TEAE) infection

    Time frame: Baseline to 29 days post cell infusion

  10. Type of infection

    Time frame: Baseline to 29 days post cell infusion

    Description of type of infection, e.g., bacterial, viral, or fungal.

  11. Donor Chimerism

    Time frame: 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).

  12. Absolute neutrophil count (ANC)

    Time frame: Baseline to 29 days post cell infusion

  13. Non-relapse mortality rate (NRM)

    Time frame: 100 days

    NRM is percentage of participants who died without recurrent or progressive disease within 100 days after allo-SCT.

  14. Relapse rate

    Time frame: 100 days

    Relapse rate is percentage of participants who relapsed within 100 days after allo-SCT

  15. GVHD incidence

    Time frame: 100 days

    GVHD incidence rate at day 100 post SCT is the percentage of participants who experienced GVHD within 100 days after allo-SCT

Study contacts

Contact information is provided by the study sponsor or research team.

Hongtau Liu, MD, PhD

CONTACT

[email protected]

608-263-6002

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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