Phase 1 Study Evaluating Pomalidomide Following CD19 CAR T-Cell Therapy in Relapsed or Refractory CD19 B-Cell Leukemia and Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell CD19CART therapy in patients with relapsed or refractory CD19 B-cell leukemias or lymphomas. This phase 1 study aims to understand if pomalidomide can improve the effects of CAR T-cell therapy, which involves modifying a patients immune cells to attack cancer cells. The study is sponsored by the University of Michigan Rogel Cancer Center and focuses on patients whose disease has returned or not responded to prior treatments. Participants receive pomalidomide orally once daily for 10 doses if their disease does not progress and they do not experience unacceptable side effects. Alongside the drug treatment, blood samples are collected to monitor CAR T-cell activity. The study tracks the expression of CAR T-cells, immune cell profiles, and levels of signaling proteins in the blood at several time points during and after treatment. Throughout the study, participants will have blood tests on days 0, 7, 14, 28, 56, and at 1 year to assess immune response and CAR T-cell presence. Researchers will monitor for adverse events especially within the first 56 days after starting pomalidomide, and will follow participants for overall and event-free survival up to 1 year. The total participation duration spans from enrollment post-CAR T-cell therapy up to one year of follow-up.

Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma