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ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)

Date

08 Oct 2016

Session

Poster Display

Presenters

Sattva Neelapu

Citation

Annals of Oncology (2016) 27 (6): 313-327. 10.1093/annonc/mdw375

Authors

S.S. Neelapu1, F.L. Locke2, N.L. Bartlett3, T. Siddiqi4, I. Braunschweig5, L.J. Lekakis6, A. Goy7, J. Castro8, O. Oluwole9, D. Miklos10, J. Timmerman11, C. Jacobson12, P.M. Reagan13, I. Flinn14, U. Farooq15, P. Stiff16, L. Navale17, M. Elias17, J. Wiezorek17, W.Y. Go17

Author affiliations

  • 1 Department Of Lymphoma/myeloma, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 2 Department Of Blood And Marrow Transplantation, Moffitt Cancer Center, 33612 - Tampa/US
  • 3 Siteman Cancer Center, Washington University School of Medicine, St. Louis/US
  • 4 Department Of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte/US
  • 5 Department Of Oncology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx/US
  • 6 Sylvester Cancer Center, University of Miami, Miami/US
  • 7 Clinical Divisions, John Theurer Cancer Center at Hackensack University Medical Center, Hackensack/US
  • 8 Moores Cancer Center, University of California San Diego, La Jolla/US
  • 9 Hematology And Stem Cell Transplantation Section, Division Of Hematology/oncology, Department Of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville/US
  • 10 Division Of Blood And Marrow Transplantation, Stanford University School of Medicine, Stanford/US
  • 11 Division Of Hematology & Oncology, Department Of Medicine, And Department Of Pathology & Laboratory Medicine, University of California, Los Angeles/US
  • 12 Department Of Medical Oncology, Dana-Farber Cancer Institute, Boston/US
  • 13 Department Of Medicine, University of Rochester Medical Center, Rochester/US
  • 14 Department Of Hematology & Oncology, Sarah Cannon Research Institute, Nashville/US
  • 15 Division Of Hematology, Oncology And Blood And Marrow Transplantation, University of Iowa Hospitals and Clinics, Iowa City/US
  • 16 Cardinal Bernardin Cancer Center, Loyola University Medical Center, Maywood/US
  • 17 -, Kite Pharma, Santa Monica/US
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Resources

Background

Diffuse large B-cell Lymphoma (DLBCL) is 30%-58% of all NHL and has an incidence of 3.8/100,000 in Europe (Tilly et al, Ann Oncol 2015). KTE-C19 is an autologous anti-CD19 CAR T cell therapy with CD28/CD3&zgr; signaling domains centrally manufactured using a streamlined 6-8–day process (Better et al, ASCO 2014). The multicenter phase 1 portion of ZUMA-1 found that KTE-C19 was safe for further study in refractory, aggressive NHL. Toxicities include generally reversible cytokine release syndrome and neurotoxicity. The phase 1 overall response rate (ORR) was 71%; complete remission (CR) rate was 57% (Locke et al, ASH 2015). Here, we describe the enrolling phase 2 portion of ZUMA-1.

Trial design

Approximately 112 patients with refractory, aggressive NHL will be enrolled into cohort 1 (approximately 72 patients with DLBCL) or cohort 2 (approximately 40 patients with primary mediastinal large B cell lymphoma or transformed follicular lymphoma). Patients will receive a fixed dose of 30 mg/m2/day fludarabine and 500 mg/m2/day cyclophosphamide conditioning chemo (chemo) x 3 days followed by a single infusion of KTE-C19 at a target dose of 2 × 106 anti-CD19 CAR T cells/kg. Eligible patients will have chemo-refractory disease (progressive disease [PD] or stable disease to most recent chemo or PD/recurrence ≤12 months of prior autologous stem cell transplant), ≥18 years old, ECOG PS 0-1, adequate marrow, renal, hepatic, and cardiac function, and prior anti-CD20 monoclonal antibody and an anthracycline-containing chemo regimen. Patients with prior CAR T cell or other genetically modified T cell therapy, clinically significant infection, or current or history of central nervous system lymphoma are ineligible. The primary objective is to evaluate KTE-C19 efficacy by ORR (CR + partial remission). Key secondary objectives include duration of response, progression-free survival, overall survival, safety, pharmacokinetics, pharmacodynamics, and predictive biomarker analyses. The study is planned at approximately 25 sites in the US and EU. Accrual began November 2, 2015.

Clinical trial identification

NCT02348216

Legal entity responsible for the study

Kite Pharma

Funding

Kite Pharma

Disclosure

S.S. Neelapu, U. Farooq: Research funding from Kite Pharma. F.L. Locke: Scientific advisory for Kite Pharma. N.L. Bartlett: Scientific advisory for Gilead. T. Siddiqi: Speaker's bureau for Pharmacyclics, Janssen, and Seattle Genetics. A. Goy: Honoraria, consultancy, speaker's bureau for Pharmacyclics and Johnson and Johnson; Honoraria and consultancy for Celgene, Takea, and Acerta; Consultancy for Infinity. D. Miklos: Research funding from Kite Pharma, Pharmacyclics, Janssen, Roche, Genentech, Novartis, Adaptive Biotechnology; scientific advisory for Pharmacyclics, Novartis, Seattle Genetics, and BMS; speaker's honoraria for Sanofi. I. Flinn: Research funding from Pharmacyclics and Janssen. L. Navale, J. Wiezorek, W.Y. Go: Employment with Kite Pharma. M. Elias: Employment from Kite Pharma. All other authors have declared no conflicts of interest.

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