A Phase II Study to Examine the Impact of CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With RelapsedRefractory B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying acute lymphoblastic leukemia ALL, a type of blood cancer, focusing on whether a second CAR T-cell therapy targeting a different marker, CD22, can extend remission after initial treatment with CD19 CAR T-cells. This phase 2 trial addresses the challenge that about half of ALL patients relapse within a year after CD19 CAR T-cell therapy. The study aims to improve long-term remission without the high risks of stem cell transplant. Participants will undergo a preparatory process including lymphodepleting chemotherapy with fludarabine and cyclophosphamide over 4 days, followed by infusion of modified CD22 CAR T-cells created from their own T cells collected via leukapheresis. Some may require hospitalization during treatment. This single-group study will monitor participants for two years to assess safety, treatment effects, and the persistence of the CAR T-cells. During the study, participants will have imaging scans, heart function tests, bone marrow biopsies, and spinal fluid collection. Researchers will evaluate toxicity, antitumor response, and overall survival at multiple time points, including one and two years post-infusion. The study involves follow-up visits over two years to track outcomes and safety, with a focus on one-year relapse-free survival after CD22 CAR T-cell treatment.

CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia