Phase 1 Study of Anti-CD19CD20CD22 CAR T-Cell Therapy with Chemotherapy for Relapsed or Resistant Lymphoid Cancers Including Leukemia and Lymphoma

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of genetically engineered anti-CD19CD20CD22 CAR T-cells following chemotherapy in patients with relapsed or refractory lymphoid cancers. These cancers include non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphocytic leukemia, and B-prolymphocytic leukemia. CAR T-cells are made by modifying a patients own immune cells to target proteins found on cancer cells, potentially improving cancer cell killing after chemotherapy prepares the body. The study involves three groups receiving different treatment schedules. All patients receive chemotherapy with cyclophosphamide and fludarabine before CAR T-cell infusion. Cohort A patients get one infusion of CAR T-cells on day 0, Cohorts B and C receive two infusions on days 0 and 7 with varying chemotherapy timing. Patients undergo heart scans and may have tissue biopsies, blood collection, and bone marrow tests throughout the study. Participants have follow-up visits at multiple time points from days 1 to 90, then months 6, 24, 36, 48, and 60, continuing annually for up to 15 years. Researchers monitor safety, immune cell behavior, treatment response, survival, and possible side effects. Various tests include echocardiography or MUGA scans, apheresis for cell collection, biopsies, and blood sampling. The study aims to find the recommended dose and better understand this CAR T-cell therapy in these blood cancers.

Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies