Phase 2 Study of M-CENK, N-803, and Gemcitabine for Platinum-Resistant Ovarian Cancer
This Phase 2 study is looking at a new combination treatment for women with high-grade ovarian cancer that has returned and is resistant to platinum-based chemotherapy. The study will include up to 20 participants and will test the safety and effectiveness of three treatments together: M-CENK (an adoptive cell therapy), N-803 (an IL-15 superagonist), and gemcitabine (a chemotherapy drug). You would receive gemcitabine, and starting in the second cycle, also M-CENK and N-803. Before starting treatment, you would have a procedure called apheresis to collect your cells for making M-CENK. Researchers will track how long you live, how long you live without the cancer getting worse, and if your tumors shrink or disappear.
- Study design
- This is a Phase 2, open-label, single-arm study, meaning all participants receive the same treatment and everyone knows what treatments are being given. The study plans to enroll up to 20 participants.
- What's involved
- You would undergo an apheresis procedure before starting treatment. You would then receive gemcitabine starting in Cycle 1, and M-CENK and N-803 starting in Cycle 2, continuing as long as M-CENK is available or you are benefiting from treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will follow participants for up to 2 years to evaluate how long they live and how long they live without the cancer getting worse.
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NCT06710288
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
Recruiting
PHASE2Ages 18–85InterventionalTreatmentImmunityBio, Inc.
~20 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:GemcitabineN-803M-CENK
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate Progression Free Survival (PFS)
Measured over Cycle 1 Day 1 through End of Study, up to 2 years
+6 more outcomes measured
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Leonard Sender, MD · STUDY_DIRECTOR · ImmunityBio, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had PD between 3 and 6 months after their last dose.
Participants who had previously received two or three lines of platinum-based therapy must have had PD while receiving the therapy or within 6 months after the last dose. 8. Participants with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. 9. Must have adequate peripheral venous access on both arms, or be willing to have temporary vascular access placed for apheresis collection, if deemed necessary by the Investigator. 10. Must be able to sit or recline with limited movement for approximately 6 hours during apheresis procedure. 11. Participants must have been previously tested for FRα. If the test result was positive, they must have been offered treatment with mirvetuximab soravtansine-gynx. 12. Agreement to practice effective contraception for female participants of childbearing potential. Female participants of childbearing potential must agree to use effective contraception for up to 7 months after completion of study treatment. Effective contraception includes surgical sterilization (eg, tubal ligation), orals, injectables, 2 forms of barrier methods (eg, diaphragm), intrauterine devices (IUDs), and hormonal therapy. 13. Eastern cooperative oncology group (ECOG) performance status of ≤ 1. 14. Major surgery must be completed and recovered at least 4 weeks prior to the first dose of study treatment. 15. Participants must meet the following organ and marrow function as defined below:
Absolute neutrophil count ≥ 1,000/mm3
Platelets ≥ 100,000/mm3
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \< 3 × ULN)
Albumin ≥ 3.0 g/dL
Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min/1.73 m2 by Cockcroft-Gault Formula (Appendix C.1)
Oxygen saturation: ≥ 90% on room air 16. Participants with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 17. Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (Appendix B.2). To be eligible for this trial, participants should be class 2B or better. 18. Expected survival \> 16 weeks. 19. Stated willingness to comply with study procedures. 20. Able to attend required study visits and return for adequate follow-up, as required by this protocol.
What this trial measures
- Evaluate Progression Free Survival (PFS)Cycle 1 Day 1 through End of Study, up to 2 years
Measured by RECIST v1.1 and iRECIST
- Evaluate Overall Survival (OS)Cycle 1 Day 1 through End of Study, up to 2 years
- Evaluate Objective Response Rate (ORR)Cycle 1 Day 1 through End of Study, up to 2 years
Measured by RECIST v1.1 and iRECIST
- Evaluate Duration of Response (DOR)From time of first response to the date of disease progression or death, up to 2 years
Measured by RECIST v1.1 and iRECIST
- Evaluate Disease Control Rate (DCR)Cycle 1 Day 1 through End of Study, up to 2 years
Measured by RECIST v1.1 and iRECIST
- Evaluate the time to progression or death on the next line of treatment (PFS2) of participants receiving M-CENK adoptive cell therapy and N-803 in combination with gemcitabine.Cycle 1 Day 1 through End of Study, up to 2 years
Measured by RECIST v1.1 and iRECIST and survival status
- Evaluate the CA-125 response rate (RR) per Gynecologic Cancer Intergroup (GCIC) CA-125 criteria.Cycle 1 Day 1 through End of Study, up to 2 years
Measured by the CA-125 result