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• W2950789181 abstract "* Authors contributed equally to this work. Introduction: CD19-specific second generation chimeric antigen receptor (CAR) T cell therapy with either CD28 or 41BB co-stimulatory domain demonstrate complete remission (CR) rates of 30-50% in relapsed/refractory (R/R) NHL and 20-30% in CLL. Concurrent expression of 4-1BBL in a CD19 CAR T cell enhances T cell proliferation, IL-2 secretion, and cytolytic activity of CAR T cells in the inhibitory tumor microenvironment (Zhao Z et al. Cancer Cell 2015). We report the outcomes of adult patients (pts) with NHL and CLL treated with escalating doses of autologous 19-28z/4-1BBL+ CAR T cells (NCT03085173). Methods: Pts with R/R NHL (DLBCL, follicular lymphoma (FL), transformed FL (tFL), Waldenström's macroglobulinemia (WM)) and CLL including Richter's transformation were eligible. Pts received conditioning chemotherapy with cyclophosphamide (Cy) alone or combined with fludarabine (Flu) followed by escalating doses of CAR T cells. For DLBCL pts, R-GemOx was the preferred bridging chemotherapy. CAR T cells were administered at dose level (DL) 1 (1x105 cells/kg), DL2 (3x105 cells/kg), DL3 (1x106 cells/kg), and DL4 (3x106 cells/kg). The primary and secondary objectives of the study was to evaluate safety of autologous 19-28z/4-1BBL CAR T cells and assess overall response rate. Results: 28 pts were enrolled with R/R CLL (n=9), de novo R/R DLBCL (n=6), tFL (n=3), FL and WM (n=5), Richter's transformation (n=4), and B-ALL (n=1). Median age of the pts was 70 (range, 53-81), and median number of prior treatments was 5 (range, 2-17). No dose-limiting toxicity (DLT) was observed. All 28 pts are at least 2 weeks from T cell infusion and evaluable for toxicity. Cytokine release syndrome (CRS) was observed in 11 pt (39.3%), one patient with a grade 3 event. Neurotoxicity was observed in 11 pts (39.3%), grade 1-2 in 8 pts and grade 3 in 3 pts. Twenty-seven patients were evaluable for response; one patient was not evaluable because of progressive multifocal leukoencephalopathy attributed to prior therapy, which developed within 1 month after CAR T cell therapy. Responses were observed at all DL. Three patients received multiple infusion of CAR T cells with response from first infusion considered evaluable. Sixteen of 27 pts (59%) achieved a CR, including 7/9 (78%) pts with DLBCL, 3/4 (75%) pts with FL, 3/9 (33%) pts with CLL, 2/3 (67%) pts with Richter's transformation, and one pt with B-ALL. The pt with WM achieved a VGPR. With a median follow-up of 169 days (24-534 days), 8 pts (29%) remain in CR. Peak CAR T cell expansion occurred at a median of 9 days after CAR T cell infusion (range, 2-82). CAR T cell detection beyond 160 days noted. Keywords: CD19; non-Hodgkin lymphoma (NHL); T-cells. Disclosures: Batlevi, C: Consultant Advisory Role: GLG, Lifesci Consulting; Honoraria: Dava Oncology; Research Funding: Janssen, Novartis, Epizyme, Xynomics, Mediimune. Palomba, M: Research Funding: Juno. Park, J: Research Funding: Juno. Brentjens, R: Stock Ownership: Juno; Research Funding: Juno." @default.
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• W2950789181 date "2019-06-01" @default.
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• W2950789181 title "PHASE I CLINICAL TRIAL OF CD19-TARGETED 19-28Z/4-1BBL “ARMORED” CAR T CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY NHL AND CLL INCLUDING RICHTER TRANSFORMATION" @default.
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