Clinical Trial

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting Phase 2
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Summary
This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-07-21; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2020-12-15
Trial Details
NCT Number NCT04484012
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Enrollment 36 participants
Start Date 2020-12-31
Primary Completion 2026-09-02 (estimated)
Study Completion 2026-09-02 (estimated)
Updated on ClinicalTrials.gov 2025-11-26