Can trained immune cells stop blood cancer relapse?
NCT ID NCT02203903
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial tests whether giving patients special immune cells, called TAA-T, after a stem cell transplant can help prevent high-risk blood cancers like acute myeloid leukemia from coming back. The cells are designed to recognize three common tumor markers and attack any remaining cancer cells. The study includes patients aged 6 months to 80 years with high-risk AML or MDS who are receiving or have received a transplant. The main goal is to see if the treatment is safe and to measure how long patients stay free of their cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tumor-associated antigen lymphocytes (TAA-T), a type of immune cell therapy designed to recognize and attack cancer cells expressing WT1, PRAME, and survivin.
- What this could lead to
- If successful, this approach could offer a new way to prevent relapse after stem cell transplant for high-risk blood cancers, potentially improving long-term survival.
- What could go wrong
- This is an early-phase trial, so safety and effectiveness are not yet proven. Risks include graft-versus-host disease, infusion reactions, and the possibility that the cells may not work as hoped.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2015
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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6 months to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Recipient Inclusion Criteria to Enter Protocol: * Aged 6 months to 80 years. * Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant. * Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease. * Karnofsky/Lansky score of ≥ 50. * Agree to use contraceptive measures during study protocol participation (when age appropriate). * Patient or parent/guardian capable of providing informed consent. * T cell chimerism \> 94% if collected from recipient of allo-HSCT Recipient Exclusion Criteria to Enter Protocol: * Patients with uncontrolled infections. * Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Pregnancy (female of childbearing potential). Recipient Inclusion Criteria for TAA-T Administration: * Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease. * Steroids less than 0.5 mg/kg/day prednisone or equivalent in the context of no escalation of treatment within the preceding 2 weeks * Karnofsky/Lansky score of ≥ 50. * Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher). * Pulse oximetry of \> 90% on room air. * Absolute neutrophil count \> 250/ µL (may be supported with Granulocyte colony-stimulating factor (GCSF)). * Agree to use contraceptive measures during study protocol participation (when age appropriate). * Patient or parent/guardian capable of providing informed consent. * LVEF \> 50% or LVSF \> 27% (performed within the last 6 months) if history of TBI \>500 cGy for arm A and B. * Total chimerism \> 50%; or if cancer cells preclude this, donor T cell chimerism \> 50% (performed within the last 6 months). Recipient Exclusion Criteria for TAA-T Administration: * Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T infusion. * No investigational therapies (under IND, not extensively studied in the current clinical context) within 28 days prior to TAA-T infusion. * Uncontrolled infections. * Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Active acute GVHD or chronic GVHD requiring escalation of treatment within preceding 2 weeks of any grade is exclusion for Arm C patients. * Pregnancy or lactating (female of childbearing potential). * Patients who have or will be receiving 2nd allogeneic HSCT Donor Inclusion Criteria: * Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation. * Aged 6 months to 80 years. * Donor or guardian of pediatric capable of providing informed consent. * Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed: * HBsAg * HB Core antibody * HIV1/2 NAT * Syphilis (T. Pallidum IgG) * HTLV I/II * CMV total * HBV/HCV NAT * West Nile Virus NAT. * Cruz (Chagas) antibody * Hepatitis C * Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing. Donor Exclusion Criteria: * Donation of cells would pose a physical or psychological risk to the donor. * Female donors of childbearing age who are known to be pregnant.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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Childrens National Medical Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Tania Jain, MD
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- A nationwide effort to map a rare blood Cancer's toll
- Can blood tests predict transplant complications?