Actively Recruiting
Phase 2 Study of M-CENK Cell Therapy and N-803 with Gemcitabine for Women with Recurrent Platinum-Resistant High-Grade Ovarian Cancer
Led by ImmunityBio, Inc. · Updated on 2026-07-01
20
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of a combination treatment involving M-CENK adoptive cell therapy, N-803, and gemcitabine in women with platinum-resistant high-grade ovarian cancer. This phase 2, single-arm study focuses on participants whose cancer has returned despite previous platinum-based chemotherapy and other therapies including bevacizumab and, if applicable, PARP inhibitors. The study aims to understand how this combination affects disease progression and survival. Participants will undergo a blood collection procedure called apheresis to gather cells needed to create M-CENK therapy. Treatment starts with gemcitabine given intravenously on specific days in 4-week cycles. From the second cycle onward, participants will also receive M-CENK cell infusions intravenously and N-803 injections under the skin. N-803 dosing continues with additional doses spaced two weeks apart after the last M-CENK infusion. Treatment continues until M-CENK cells are no longer available or disease progression is confirmed, unless the investigator believes the participant is still benefiting. During the study, participants are closely monitored through regular assessments including imaging to evaluate tumor response and progression. Safety is evaluated through laboratory tests, vital signs, and tracking adverse events. After completing or stopping treatment, participants will be followed every 12 weeks for up to one year to monitor survival and disease status. The study measures several outcomes such as progression-free survival, overall survival, response rates, and disease control, assessing the impact of the combined therapies over time.
CONDITIONS
Brief Title
A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer
Research Team
J
Jayson Garmizo
K
Kamin Personett
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