RecruitingPhase 2NCT04484012

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

A Phase 2 Study to Evaluate CD19-Specific Chimeric Antigen Receptor (CAR)-T Cells Combined With Acalabrutinib for Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Sponsor

City of Hope Medical Center

Enrollment

36 participants

Start Date

Dec 31, 2020

Study Type

INTERVENTIONAL

Conditions

Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of CAR T-cell therapy (specially engineered immune cells that target a protein called CD19 on cancer cells) together with a targeted drug called acalabrutinib, for patients with mantle cell lymphoma that has returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older with relapsed or refractory mantle cell lymphoma - You have had prior treatment that did not work or stopped working - You have tumor tissue available from a prior biopsy - Your overall health status allows for treatment (ECOG performance 0–2) **You may NOT be eligible if...** - You have active brain involvement from lymphoma - You have significant organ dysfunction - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Given PO

BIOLOGICALCD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes

Given IV

Locations(1)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

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NCT04484012

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