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Not yet recruitingPhase 1

Allogeneic iNKT Cell Therapy (agenT-797) After SCT

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether agenT-797, a cell therapy, is safe for adults getting a blood-forming stem cell transplant from a donor. It also tracks medical problems that happen after treatment. Participants get agenT-797 through a vein about 7 days after their transplant.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older when you agree to join.
  • You must be expected to get a blood-forming stem cell transplant from a donor.
  • All donor types are allowed, including related and unrelated donors with full or partial matches.
  • All types of treatment used to prepare for the transplant are allowed.
  • Your Karnofsky score, which measures how well you do daily activities, must be above 70.
  • Listed diseases include acute myeloid leukemia (AML) with medium- or high-risk features, or AML that has come back; and chronic myeloid leukemia (CML) in a faster-growing or advanced stage. These are blood cancers.
  • Other listed diseases include myelodysplastic syndrome (MDS), a blood cell disorder, with medium- or high-risk features; and acute lymphoblastic leukemia (ALL), a blood cancer, with high-risk features or that has come back.
  • People getting a donor stem cell transplant as standard treatment for another condition may also qualify.

Who can't join

  • People with primary myelofibrosis, a disease that causes scarring in bone marrow, cannot join the phase that tests increasing doses. They may be able to join the later phase that includes more people.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

WI