Study of Anti-CD19 CAR T-cell Therapy Combined with Lenalidomide for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are studying adult patients with relapsed or refractory chronic lymphocytic leukemia CLL who have been treated with ibrutinib for at least 3 months. This Phase III open-label trial evaluates the safety and effectiveness of combining anti-CD19 CAR T-cell therapy with the drug lenalidomide. The study aims to explore the safety profile, pharmacokinetics of CAR T cells, and measure treatment responses including disease progression and survival rates. Participants receive ibrutinib daily for 3 months before receiving a CAR T-cell infusion. Before leukapheresis, obinutuzumab is given to reduce circulating leukemia cells. Lymphodepletion chemotherapy is administered before the CAR T-cell infusion. Patients are assigned to one of three dose levels of CAR T cells, all combined with lenalidomide taken orally for 7 days. Depending on their measurable residual disease status at day 28, patients receive additional lenalidomide alone or with obinutuzumab over several cycles as consolidation or maintenance therapy. During the study, participants are closely monitored for adverse events such as cytokine release syndrome and infections for 24 months. Researchers assess treatment responses including overall response rates, progression-free survival, and minimal residual disease negativity using flow cytometry. The trial involves ongoing safety and efficacy evaluations over two years, with close follow-up to understand the effects of this combined therapy approach for CLL.

Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.