Trials / Active Not Recruiting

Active Not RecruitingNCT04257578

Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma

Acalabrutinib in Combination With Anti-CD19 Chimeric Antigen Receptor T-Cells (CART) in B-Cell Lymphoma

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 23 (actual)

Sponsor: University of Washington · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.

Detailed description

OUTLINE: Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib orally (PO) every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel intravenously (IV) at 36-96 hours after completion of lymphodepleting chemotherapy. After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Conditions

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Given PO
BIOLOGICAL	Axicabtagene Ciloleucel	Given IV

Timeline

Start date: 2020-12-02
Primary completion: 2025-08-07
Completion: 2031-03-01
First posted: 2020-02-06
Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04257578. Inclusion in this directory is not an endorsement.