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.
I. Evaluate the safety of adding CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched
T-lymphocytes (CD19 CAR T cells) to acalabrutinib treatment. (Safety Lead-in) II. Estimate
the complete response (CR) rate within 6 months after adding CD19 CAR T cells to
acalabrutinib treatment. (Phase 2)
I. Assess best response, time to and duration of CR. II. Estimate the 1-year progression free
survival (PFS) rate and overall survival (OS).
III. Describe the full toxicity profile.
I. Assess CD19-CAR T cell persistence. II. Assess CD19-CAR T cell activity as measured by
CD19 B cell aplasia. III. Describe the duration of CR from completion of acalabrutinib. IV.
Describe immunogenicity of CD19-CAR T cells in the presence of the BTK inhibitor.
V. Characterize CD19 expression on tumor cells. VI. Describe cytokine profile after CD19-CAR
T cell infusion. VII. Determine BTK and PLCG2 mutational status prior to treatment.
Patients receive acalabrutinib orally (PO) twice daily (BID) on days -5 to 28 of cycle 1 and
on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells intravenously (IV)
on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the
absence of disease progression or unacceptable toxicity. Patients who have not attained CR
after the first disease assessment and tolerated the initial CAR T cell infusion may receive
a second CAR T cell infusion in cycle 2.
After completion of study treatment, patients are followed up at 3, 6 and 12 months, then
yearly for up to 15 years post CAR T cells infusion.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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