CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 23 enrolled / 23 target
Drug / intervention
Acalabrutinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04257578
NCT04257578Phase 1ActiveUpdate Overdue (0.3/mo)Completion was 10mo ago

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

University of Washington·interventional·Posted Feb 6, 2020·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating Acalabrutinib and Axicabtagene Ciloleucel for B-Cell Non-Hodgkin Lymphoma and 7 related conditions. Active but no longer recruiting, targeting 23 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Timeline

Phase 1Active
202020212022202320242025202620272028202920302031
First PostedFeb 6, 2020
Enrollment StartDec 2, 2020
Primary CompletionAug 7, 2025
Study CompletionMar 1, 2031
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.4 years ago

Arms & Interventions

Treatment (acalabrutinib, axicabtagene ciloleucel) - HIV-negative Cohortexperimental

Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy.

Drug: AcalabrutinibBiological: Axicabtagene Ciloleucel
Treatment (acalabrutinib, axicabtagene ciloleucel) - HIV-positive Cohortexperimental

Beginning up to 3 weeks and at least 24 hours prior to leukapheresis, patients receive acalabrutinib PO every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also receive axicabtagene ciloleucel IV at 36-96 hours after completion of lymphodepleting chemotherapy.

Drug: AcalabrutinibBiological: Axicabtagene Ciloleucel

Interventions

Acalabrutinibdrug

Given PO

Axicabtagene Ciloleucelbiological

Given IV