Anti CD19 Chimeric Antigen Receptor (CAR) T-cell therapy has transformed the care of relapsed & refractory aggressive B cell Lymphoma. However, financial toxicity and manufacturing time represent barriers to its widespread implementation.
Study applicability, toxicity, and efficacy of a locally produced autologous CD19-directed CAR-T cell product.
We performed a phase 1b/2 clinical trial with a point-of-care (POC) CAR T-cell product that contains a CD28 costimulatory domain. Adult patients with aggressive B cell lymphoma or transformed low-grade lymphoma who received at least two prior regimens were eligible.
A total of 73 patients, with a median age of 49 years, met inclusion criteria. CAR-T production time from apheresis was 10 days (IQR 10-11), negating the need for bridging chemotherapy. Overall and complete response rates were 62.5% and 37.5%. Median progression-free and overall survival were 3.7 and 12.1 months, respectively. Overall and progression-free survival at 12 months were 52.1% (CI: 40.8%-66.5%) and 40% (CI: 30%-53.7%), respectively. Patients who achieved response had longer progression-free and overall survival. Grade 3-4 CRS was observed in 9.5% of the patients, and ICANS grade 3-4 in 21.9%. No deaths occurred due to CAR T-cell toxicity. Fifteen patients (20%) underwent allogeneic stem cell transplantation at a median time of 60 days post CAR T-cell therapy; 8 were alive at last follow-up. Of the six patients that underwent the transplant in complete response 2 deceased due to toxicity.
POC CAR-T cells are a feasible therapeutic option in aggressive B-cell lymphoma. They provide good efficacy while minimizing production time and the need for bridging therapy.

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