Supercharged immune cells take on blood cancers in new trial
NCT ID NCT01853631
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for people with advanced B-cell lymphoma or leukemia that has returned or not improved after standard therapy. Researchers take a patient's own T-cells, add a special receptor (CAR) that targets the CD19 protein on cancer cells, and also add extra stimulatory proteins (CD28 and CD137) to help the cells work better and last longer. The goal is to find a safe dose and see if these engineered T-cells can control the cancer.
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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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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Feb 2014
- Expected to finish
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Feb 2036
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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Up to 75 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.
Inclusion Criteria: PROCUREMENT Referred patients (or respective donors) will initially be consented for procurement of blood for generation of the transduced ATL. Eligibility criteria at this stage include: * Diagnosis of recurrent B-cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. * CD19-positive tumor (result can be pending at this time). * Age \<= 75 years. The first 3 patients treated on the study should be adults (\>= 18 years). * Hgb greater than or equal to 7.0 (can be a transfused value) * If pheresis required to collect blood: * Creatinine \< 1.5 x upper limit normal * AST \<1.5 × upper limit normal * PT and APTT \<1.5 × upper limit normal * Informed consent explained to, understood by and signed by patient/guardian (and donor, where applicable). Patient/guardian given copy of informed consent. TREATMENT * Diagnosis of recurrent B-cell lymphoma leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. * CD19-positive tumor. * Age \<= 75 years. The first 3 patients treated on the study should be adults (\>= 18 years). * Bilirubin less than 3 times the upper limit of normal. * AST less than 5 times the upper limit of normal. * Estimated GFR \> 50 mL/min * Pulse oximetry of \> 90% on room air * Karnofsky or Lansky score of \> 60%. * Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated. * Available autologous or syngeneic activated peripheral blood T cell products (CD28ζ and CD28/CD137ζ) with more than or equal to 15% expression of CD19.CAR determined by flow cytometry. * Life expectancy of greater than 12 weeks. * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom. * Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. Exclusion Criteria: PROCUREMENT * Active infection requiring antibiotics. * No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry. TREATMENT * Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks. (Note treatment with PD1/PDL1 inhibitors is allowed.) * History of hypersensitivity reactions to murine protein-containing products. * Pregnant or lactating. * Tumor in a location where enlargement could cause airway obstruction. * Active infection with HIV or HTLV.
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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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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- Patient's own t cells engineered to hunt lymphoma in early trial
- Two-Drug combo targets tough Non-Hodgkin's lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Immunotherapy injection tested against Hard-to-Treat childhood lymphoma