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Supercharged donor cells take aim at blood cancers

NCT ID NCT02494167

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This early-phase trial tests whether specially trained immune cells from a donor can safely target and kill cancer cells in people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after a stem cell transplant. The cells are grown in a lab to recognize four proteins common on these cancer cells. The main goal is to find the safest dose and see if the cells can reduce or control the disease.

What this could mean

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

Active substance
donor-derived T cells trained to recognize tumor proteins (WT1, NY-ESO-1, PRAME, Survivin)
What this could lead to
If it works, this could offer a new way to control AML or MDS after a stem cell transplant, potentially reducing the risk of relapse.
What could go wrong
This is an early Phase 1 trial with only 44 participants, so safety and effectiveness are not yet proven. The treatment may cause side effects or fail to shrink the cancer.

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

30 people

The number who actually took part.

Started

Feb 2016

Finished

Jun 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as; (i) Adjuvant therapy for AML/MDS (Group A) or (ii) Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B) Residual disease at the time of transplant or post transplant relapse is defined as PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood or any other extramedullary sites. Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues of any of the following: (i) Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation. (ii) Expression of a leukemia associated antigen known to be a marker for residual disease like WT1. (iii) A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or HLA-DR+) post-transplant at a level of ≥ 0.01%. (ix) Mixed donor chimerism (\> 20%). 2. Life expectancy ≥ 6 weeks. 3. Karnofsky/Lansky score of ≥ 50. 4. Patient or parent/guardian capable of providing informed consent. 5. Bilirubin ≤ 2X upper limit of normal. 6. AST ≤ 3X upper limit of normal. 7. Undergoing stem cell transplant at CAGT. 8. Serum creatinine ≤ 2X upper limit of normal. 9. Hgb ≥ 7.0 g/dL (can be transfused). 10. Pulse oximetry of \> 90% on room air. 11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. Male partner should use a condom. 12. Available donor-derived multiTAA-specific T cell line. 13. No other investigational anti-neoplastic therapy for one month prior to entry in this study. Exclusion Criteria: 1. Patients receiving ATG or Campath within 28 days of infusion. 2. Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion. 3. Less than 30 days post-allogeneic stem cell transplant. 4. Severe intercurrent infection. 5. Evidence of GVHD \> Grade II. 6. Pregnant or lactating. 7. Currently taking corticosteroids (\> 0.5 mg/kg/day prednisone or equivalent).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.