This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.
Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R/R CD19+ Bcell leukemias and lymphomas.
Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.
>= 18 years in age at time of enrollment
Subject is able to swallow pills/tablets
Patients with known progressive or refractory disease.
Active grade >= 2 acute or chronic graft versus host disease (GVHD)
Active cytokine release syndrome (CRS) grade >= 2
Active immune effector cell associated neurotoxicity (ICANS) grade >= 2
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Pomalidomide
DrugGiven PO
Incidence of adverse events
Will assess the safety and tolerability of pomalidomide following CD19 chimeric antigen receptor T-cell (CD19CART) therapy for recurrent/refractory B-cell leukemia/lymphoma. Hematologic and non-hematologic toxicity within the first 56 days following the initiation of pomalidomide will be monitored. All observed toxicities, including dose-limiting toxicity will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), duration, and reversibility or outcome. Tables will be created to summarize toxicities.
CD19CART transgene expression
Anti-CD19 (FMC63) CAR-T qPCR assay
CD19CART transgene expression
A Spaghetti plot of individual transgene expression levels will be presented through 1-year post-pomalidomide initiation, with a population average superimposed on the plot.
Overall survival
Kaplan-Meier estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Subject to available event rates for model convergence, a Cox proportional hazards model with transgene expression as a continuous predictor will be used to explore potential association with overall survival.
Event-free survival (EFS)
1-year EFS estimates with confidence intervals will be presented and proportions will be accompanied by 95% confidence intervals. Events will be defined as disease relapse, progression, or death due to any cause.
Click on the lead sponsor to view all of their trials.
