Journal
MOLECULAR THERAPY
Volume 25, Issue 1, Pages 285-295Publisher
CELL PRESS
DOI: 10.1016/j.ymthe.2016.10.020
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Funding
- Kite Pharma
- Moffitt Cancer Center Support Grant [P30 CA076292]
- MD Anderson Cancer Center Support Grant [P30 CA016672]
- National Cancer Institute Cancer Clinical Investigator Team Leadership Award [P30 CA076292-1854]
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Outcomes for patients with refractory diffuse large B cell lymphoma (DLBCL) are poor. In the multicenter ZUMA-1 phase 1 study, we evaluated KTE-C19, an autologous CD3 zeta/CD28-based chimeric antigen receptor (CAR) T cell therapy, in patients with refractory DLBCL. Patients received low-dose conditioning chemotherapy with concurrent cyclophosphamide (500 mg/m(2)) and fludarabine (30 mg/m2) for 3 days followed by KTE-C19 at a target dose of 2 x 10(6) CAR T cells/kg. The incidence of dose-limiting toxicity (DLT) was the primary endpoint. Seven patients were treated with KTE-C19 and one patient experienced a DLT of grade 4 cytokine release syndrome (CRS) and neurotoxicity. Grade >= 3 CRS and neurotoxicity were observed in 14% (n = 1/7) and 57% (n = 4/7) of patients, respectively. All other KTE-C19-related grade >= 3 events resolved within 1 month. The overall response rate was 71% (n = 5/7) and complete response (CR) rate was 57% (n = 4/7). Three patients have ongoing CR (all at 12+ months). CART cells demonstrated peak expansion within 2 weeks and continued to be detectable at 12+ months in patients with ongoing CR. This regimen of KTE-C19 was safe for further study in phase 2 and induced durable remissions in patients with refractory DLBCL.
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