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ACTIVE NOT RECRUITING
NCT05044039
PHASE1

Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Phase I Dose Escalation and Dose Expansion Study of Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2022-02-28

Completion Date

2030-05-22

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Duvelisib

Patients should take duvelisib at approximately the same time every day, with or without food.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States