drugset / Trial / NCT05044039
Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy
Phase 1
Active not recruiting
42 enrolled
Washington University School of Medicine
National Cancer Institute (NCI) · collabSecura Bio, Inc. · collabThe Foundation for Barnes-Jewish Hospital · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duvelisib | Small molecule | 15 mg | Oral |
| Subject | Duvelisib | Small molecule | 25 mg | Oral |