Donor immune cells show promise against returning blood cancers
NCT ID NCT02050347
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment for people with certain blood cancers (lymphoma or leukemia) that have returned after a stem cell transplant. Researchers take immune cells called T cells from the original stem cell donor, modify them to recognize and attack cancer cells (using a special receptor called CAR), and give them to the patient. The main goals are to find the safest dose and to see if this approach can control the cancer without causing severe side effects.
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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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7 people
The number who actually took part.
- Start date
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Apr 2014
- Expected to finish
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Dec 2030
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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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: PROCUREMENT * Group A: CD19+ B-ALL undergoing allogeneic HSCT or Group B: CD19+ B cell CLL or NHL undergoing allogeneic HSCT * Life expectancy of ≥12 weeks. * Patient has an appropriate donor identified for hematopoietic stem cell transplantation TREATMENT * Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B) * Residual disease at the time of transplant (bulky or minimal) or post transplant relapse as evidenced by PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy or in the peripheral blood. MRD will be defined as detection in blood or marrow of any of the following: * Any leukemia specific marker (such as t(9:22) or t(4:11)) documented in the patient's leukemia cells pre transplant on a post transplant evaluation. * An immune globulin rearrangement known to be a disease marker for this patient post transplant. * A leukemia specific phenotype post transplant at a level of ≥ 0.01% * Mixed donor chimerism (any level) * Life expectancy ≥ 6 weeks * Karnofsky/Lansky score ≥ 50%. * Bilirubin ≤ 2 times the upper limit of normal. * AST ≤ 3 times the upper limit of normal. * Estimated GFR \> 50 mL/min * Hgb ≥ 7.0 (can be a transfused value) * Pulse oximetry of \> 90% on room air * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after ATL infusion. The male partner should use a condom. * Available allogeneic activated peripheral blood T cell products with \>=15% expression of CD19.CAR-CD28ζ determined by flow cytometry (cell dose is based on total cell numbers and not individual antileukemic cell numbers). * No other investigational antitumor therapy for one month prior to entry in this study. * Patients or legal guardians must sign an informed consent. Exclusion Criteria: * Severe intercurrent infection. * Evidence of GVHD \> grade II. * Pregnant or lactating. * History of hypersensitivity reactions to murine protein-containing products. * Currently taking corticosteroids (\>0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD.
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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.
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- Supercharged immune cells take aim at cancer and viruses in one shot
- Engineered t cells with a kill switch aim to make stem cell transplants safer
- Gut bacteria may hold key to chemo side effects
- New 'In-Body' CAR-T therapy takes aim at Hard-to-Treat lymphoma
- Experimental 'In-Situ' vaccine aims to train immune system against three cancers