drugset / Trial / NCT05044039

Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

NCT05044039

Non-randomizedSequentialOpen-labelTreatment

Summary

While chimeric antigen receptor T-cell (CAR T-cell) therapy produces impressive response rates in heavily pre-treated patients, early loss of response remains a barrier. One potential mechanism of relapse is limited CAR T-cell persistence. Pre-clinical research shows that PI3K inhibition represents an intriguing mechanism for increasing CAR T-cell persistence that is easily reversible and CAR T-cell agnostic. The investigators hypothesize that PI3K inhibition with duvelisib would be safe, may provide effective prophylaxis against cytokine release syndrome (CRS), and may enhance the persistence and efficacy of CAR T-cells in the treatment of hematologic malignancies.

Timeline

Start
2022-02-28
Primary completion
2026-01-06
Completion
2030-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Duvelisib Small molecule 15 mg Oral
Subject Duvelisib Small molecule 25 mg Oral