Supercharged donor cells take aim at blood cancers
NCT ID NCT02494167
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
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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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30 people
The number who actually took part.
- Started
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Feb 2016
- Finished
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Jun 2026
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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.
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
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?