RecruitingPhase 1NCT06340737

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas

Sponsor

Stanford University

Enrollment

148 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Burkitt Lymphoma Hairy Cell Leukemia Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Large B-cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized immune cell therapy called CD22 CAR-T — where a patient's own immune cells are genetically modified to recognize and destroy lymphoma cells that carry the CD22 protein. It targets relapsed or treatment-resistant B-cell lymphomas including follicular lymphoma and mantle cell lymphoma. **You may be eligible if...** - You have follicular lymphoma (grade 1–3a) that has come back or not responded after at least 2 lines of treatment (including an anti-CD20 antibody) — OR relapsed within 24 months of starting initial chemotherapy - You have mantle cell lymphoma or another eligible B-cell lymphoma that has relapsed or is resistant to at least 2 prior therapies - Your overall health is adequate to undergo the procedure **You may NOT be eligible if...** - You have not tried the required minimum number of prior therapies - You have significant organ dysfunction or health conditions preventing safe participation - Your lymphoma has specific aggressive features not covered by the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD22CART Infusion

Dosing and Administration Participants will be hospitalized to receive treatment with CD22CART, if not previously hospitalized, and will remain hospitalized for approximately 5 to 7 (±2) days. Patients may be discharged once all AEs have resolved to Grade 1 or better, or at the discretion of the treating physician. Participants may be discharged with non critical and clinically stable or slowly improving toxicities (e.g., renal insufficiency, cytopenias) even if \> Grade 1, if deemed appropriate by the investigator.