Immunotherapy Under Study in Resistant CLL: ZUMA-8 Trial
Posted: Monday, September 23, 2019
Ian Flinn, MD, PhD, of the Sarah Cannon Research Institute in Nashville, and colleagues are conducting a phase I/II trial to evaluate the autologous anti-CD18 chimeric antigen receptor T-cell therapy KTE-X19 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Dr. Flinn presented the rationale behind the ZUMA-8 trial at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract TPS7566) and published the study details in the Journal of Clinical Oncology.
This trial is in its early stages and is currently enrolling patients who have relapsed or refractory CLL on two or more prior treatment regimens. In addition, the trial is looking for patients who have had disease progression on ibrutinib, an Eastern Cooperative Oncology Group performance status of 0 or 1, and have adequate organ function. Phase 1 of this trial is looking to enroll 12 to 18 patients to determine dose-limiting toxicities with a 6+3 dose escalation/de-escalation design. An additional 30 patients may be enrolled to evaluate the agent’s efficacy and safety.
Phase II of ZUMA-8 will enroll approximately 60 more patients to evaluate the efficacy and safety of KTE-X19. Patients will undergo leukapheresis with the option for bridging therapy afterward. Cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) conditioning chemotherapy will be given 5, 4, and 3 days before KTE-X19 therapy is initiated. KTE-X19 will be given at 0.5, 1, or 2 x 106 KTE-X19 cells/kg.
The primary endpoint for phase 1 of the trial is the incidence of dose-limiting toxicities, and phase 2 will assess objective response rate. Other endpoints include complete remission, minimal residual disease negativity rate, duration of response, progression-free survival, overall survival, safety, and patient-reported outcomes.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
