NCT05044039

Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-hodgkin Lymphoma
• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Duvelisib	Patients should take duvelisib at approximately the same time every day, with or without food.

Timeline

• Start date: 2022-02-28
• Primary completion: 2026-01-06
• Completion: 2030-05-22
• First posted: 2021-09-14
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study