Phase III Study of Anti-CD19 CAR T-Cell Therapy with Chemotherapy and Rituximab for Adults with Advanced B-Cell Leukemias Including CLL, SLL, and ALL

What this Trial Is About

Chronic lymphocytic leukemia CLL, small lymphocytic lymphoma SLL, and B-cell acute lymphoblastic leukemia or lymphoma ALL are blood cancers affecting certain white blood cells and can be challenging to treat when advanced. Researchers are studying anti-CD19 chimeric antigen receptor CAR T cell therapy, which modifies a persons T cells to target the CD19 protein found on these cancer cells. This trial aims to assess the safety and overall response rate of this novel therapy in patients with advanced CLL, SLL, or ALL. Participants will receive a treatment regimen starting with two doses of rituximab and a conditioning chemotherapy including cyclophosphamide and fludarabine to reduce leukemia burden. After this, their T cells will be collected through leukapheresis, genetically modified to express the anti-CD19 CAR, and infused back into their bloodstream. The dose of CAR T cells will be escalated to find the optimal level, followed by a mandatory nine-day hospital stay for monitoring. Outpatient follow-up visits will then continue regularly, with long-term monitoring planned for up to 15 years. During the study, participants will undergo imaging scans, heart function tests, and tissue biopsies to confirm CD19 expression. Researchers will monitor safety, response rates, adverse events, and duration of responses over five years and beyond. Follow-up visits will occur at set intervals after infusion, and participants must agree to long-term gene therapy monitoring. The study includes detailed assessments to track treatment effects and potential toxicities, ensuring comprehensive care throughout participation.

Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias