Engineered T-Cells take on blood cancers in early trial
NCT ID NCT00709033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new type of cell therapy for people with advanced B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia (CLL) that had returned or not responded to standard treatments. Researchers took patients' own immune cells (T-cells) and added a special receptor (CD19-CD28) or trained them to recognize the Epstein-Barr virus (EBV) to help them attack cancer cells more effectively. The main goals were to find a safe dose and see how long the modified cells lasted 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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3 people
The number who actually took part.
- Start date
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Jul 2009
- Finished
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May 2025
- 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: FOR TREATMENT: * Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. * CD19-positive tumor * EBV seropositivity (in patient and donor, as applicable) * Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study. * Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks. * No treatment with rituximab within the previous 8 weeks. * ANC \> 500, Hgb \> 8.0\* * Bilirubin less than 3 times the upper limit of normal\* * AST less than 5 times the upper limit of normal\* * Serum creatinine less than 3 times upper limit of normal\* * Pulse oximetry of \> 90% on room air\* * Adequate pulmonary function with FEV1, FVC and DLCO \>35%\* of expected corrected for hemoglobin * Karnofsky or Lansky score of \> 60%. * Available autologous or syngeneic transduced EBV-specific cytotoxic T lymphocytes and peripheral blood T-cells with 15% or greater expression of CD19CAR determined by flow-cytometry. * Patients or legal guardians must understand and 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. * 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: * 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, HBV, HCV or CMV.
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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.
- Double-Drug attack on Hard-to-Treat lymphomas
- Patient's own t cells engineered to hunt lymphoma in early trial
- Immunotherapy injection tested against Hard-to-Treat childhood lymphoma
- Two-Drug combo aims to push CLL into deep remission
- Vaccine aims to train immune system against blood cancers
- Can a new BTK inhibitor outsmart resistance in CLL?