AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas (NCT06340737) | Clinical Trial Compass
RecruitingPhase 1
AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas
United States148 participantsStarted 2024-03-29
Plain-language summary
This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.
. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.
. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \<11 g/dL), thrombocytopenia (platelets\<100 x 10\^9 /L), or neutropenia (absolute neutrophil count below 1.5 x 10\^9/L); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort.
Timeframe: 6 years
2
Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)
Timeframe: 6 years
3
Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL)
. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.
. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL
. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.
. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.