Engineered immune cells take aim at blood cancers
NCT ID NCT00586391
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment for people with certain B-cell blood cancers (lymphoma, ALL, or CLL) that have returned or not responded to standard therapy. The treatment uses the patient's own T cells, which are modified in the lab to recognize and attack cancer cells carrying a marker called CD19. The main goals are to find a safe dose and to see how long the modified cells survive in the body.
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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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14 people
The number who actually took part.
- Start date
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Feb 2009
- Expected to finish
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Jul 2029
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: Patients must meet the following eligibility criteria to be included: 1. Recurrent B cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. If a patient is less than 18, the lymphoma/leukemia is highly aggressive (i.e. lymphoblastic, Burkitt, ALL). 2. Life expectancy of at least 12 weeks 3. Recovered from the toxic effects of all prior chemotherapy before entering this study 4. ANC greater than 500, HgB greater than 8.0 5. Bilirubin less than 3 times the upper limit of normal 6. AST less than 5 times the upper limit of normal 7. Serum creatinine less than 3 times upper limit of normal 8. Pulse oximetry of greater than 90% on room air 9. Karnofsky/Lansky score of greater than 60% 10. Available autologous transduced peripheral blood T-cells with greater than/=15% expression of CD19CAR determined by flow-cytometry 11. 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 12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom EXCLUSION CRITERIA: 1. History of hypersensitivity reactions to murine protein-containing products 2. Pregnant or lactating 3. Tumor in a location where enlargement could cause airway obstruction 4. Currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks
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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.
- 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
- Two-Drug combo aims to push CLL into deep remission
- Antibody-Drug combo tested to stop leukemia from returning after transplant
- Can a new BTK inhibitor outsmart resistance in CLL?