October 2016 VOL 7, NO 9

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Clinical Research

46. Interdisciplinary Management of Chemorefractory NHL Patients Treated with KTE-C19 (Anti-CD19 CAR T Cells) in Phase 1 of the ZUMA-1 Clinical Study

Alix Beaupierre,1 Amy Patterson,1 Nicole Kahle,1 Frederick L. Locke,1 Sattva S. Neelapu,2Nancy L. Bartlett,3 Tanya Siddiqi,4 Julio C. Chavez,5 Chitra M. Hosing,6 Amanda Cashen,3 Lihua E. Budde,4 Lynn Navale,7 Yizhou Jiang,7 Meg Elias,7 Jeff Aycock,7 Jeff Wiezorek,7 William Y. Go7
1Department of Blood and Marrow Transplantation, Moffitt Cancer Center, Tampa, FL; 2Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX; 3Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO; 4Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA; 5Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL; 6Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX; 7Kite Pharma, Santa Monica, CA 

Objectives: Patients with chemorefractory non-Hodg­kin lymphoma (NHL) have poor response to standard therapy and short overall survival. The objectives of the phase 1 ZUMA-1 trial were to evaluate the safety and efficacy of KTE-C19, an autologous, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with chemorefractory NHL.

Methods: Patients received a dose of 2 × 106 KTE-C19 CAR T cells/kg after low-dose conditioning chemotherapy with cyclophosphamide and fludarabine. Eligible patients had chemorefractory disease or progressive disease ≤12 months after autologous stem cell transplant, aggressive B-cell NHL, and Eastern Cooperative Oncology Group 0/1 performance status. This study was funded by Kite Pharma and supported in part by the Leukemia & Lymphoma Society Therapy Acceleration Program. The blood and marrow transplant (BMT) clinical nurse specialist, education specialist, and nurse coordinators developed patient education materials and helped streamline processes and patient experiences throughout the study.

Results: As of April 15, 2016, 7 patients received KTE-C19. Overall response rate was 71%, including 4 of 7 (57%) patients with complete response (CR; 3 CRs ongoing at 9+ months) and 1 (14%) with partial response. One patient had a dose-limiting toxicity (DLT) of grade 4 encephalopathy and cytokine release syndrome (CRS) and grade 5 intracranial hemorrhage unrelated to KTE-C19. CAR T-cell–associated toxicity included CRS, a rapid and large release of cytokines into the bloodstream resulting in fever, hypotension, hypoxemia, organ toxicity, and neurotoxicity, which may manifest as confusion, aphasia, delirium, and tremors. One (14%) patient had grade ≥3 CRS, and 4 (57%) patients had grade ≥3 neurotoxicity. Except for the patient with DLT, all grade ≥3 KTE-C19–related toxicity resolved. These data were previously presented in part at ASCO 2016 (Abstract 7559).

Conclusions: KTE-C19 can provide durable CR after a single dose in patients with refractory aggressive NHL. A subset of patients experiencing high-grade CRS and neurotoxicity required close monitoring by nursing staff to manage symptoms. KTE-C19 had manageable toxicities, and the phase 2 portion of ZUMA-1 is ongoing (NCT02348216). BMT nurse coordinators were essential in organizing the patient’s care before and after treatment, providing up-front education about the study and potential treatment-related toxicities, and supporting caregivers and patients receiving CAR T-cell therapy.

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