Engineered t cells take on tough leukemia and lymphoma
NCT ID NCT00466531
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a two-part treatment for people with relapsed or chemotherapy-resistant B-cell leukemia or lymphoma. First, patients receive a chemotherapy drug (cyclophosphamide) to help prepare the body. Then, they get an infusion of their own T cells that have been genetically modified in the lab to recognize and attack cancer cells carrying the CD19 protein. The study aims to check safety and how well this approach works in up to 50 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified T cells (CAR T-cells) and cyclophosphamide chemotherapy
- What this could lead to
- If successful, this could point toward a new treatment option for patients with hard-to-treat B-cell cancers that have come back after standard therapy.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply to everyone. There are risks from the chemotherapy and the modified T cells, including severe immune reactions.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
50 people
The number who actually took part.
- Start date
-
Mar 2007
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: • Patients must have the following CD19+ B cell leukemia or lymphoma either with relapsed or chemotherapy-refractory disease or with evidence of residual disease following therapy. In all cases, patient's disease must be confirmed at MSKCC. * CLL: Patients must have a diagnosis of CLL as evidenced by flow cytometry, bone marrow histology, and/or cytogenetics. * Other low grade B-cell neoplasms are eligible for study, such as small lymphocytic lymphoma (SLL), follicular lymphoma, Waldenstrom's macroglobulinemia, hairy cell leukemia, marginal zone lymphomas, and mantle cell lymphomas. * Creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x normal, PT and PTT ≤ 2x normal outside the setting of stable chronic anticoagulation therapy, granulocytes ≥1,000/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support * Adequate cardiac function (LVEF ≥40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment. * Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry. * Life expectancy of \> 3 months. Exclusion: * Karnofsky performance status \<70. * CLL patients with active transformed disease (Richter's transformation) are ineligible for enrollment on this study. * Patients with following cardiac conditions will be excluded: * New York Heart Association (NYHA) stage III or IV congestive heart failure * Myocardial infarction ≤6 months prior to enrollment * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration * History of severe non-ischemic cardiomyopathy with EF ≤20% * Patients with HIV, hepatitis B or hepatitis C infection are ineligible. * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Follicular lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Two-Drug combo aims to push CLL into deep remission