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Can donor immune cells tame stem cell transplant risks?

NCT ID NCT07758218

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether an experimental cell therapy called agenT-797 is safe for people receiving a stem cell transplant for blood cancers like leukemia or myelodysplastic syndrome. Participants get an infusion of agenT-797 about a week after their transplant. The main goal is to check for side effects and see if it helps reduce complications like graft-versus-host disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
agenT-797, an off-the-shelf cell therapy made from donor iNKT cells
What this could lead to
If safe, this could help prevent complications like graft-versus-host disease after stem cell transplants, improving recovery and survival.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet proven. There may be unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive lymphoid neoplasm myelodysplastic syndrome Myelodysplastic Syndromes myeloid neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Allogenic stem cell transplantation Chronic myeloid leukemia Lymphoid malignancies Myelodysplastic syndrome Myeloid malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

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