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
← catalyst calendarNCT06710288 · readout ≤ 285 d
Sponsored by ImmunityBio, Inc. (industry) · IBRX — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
20estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-06 | actual | When the study began enrolling |
| Primary completion | May 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Platinum-resistant Ovarian Cancer
Interventions
- Drug: Gemcitabine — also filed as gemcitabine hydrocholoride, Gemzar
- Biological: N-803
- Biological: M-CENK — also filed as Autologous Memory Cytokine Enriched Natural Killer
Primary outcomes
what the primary-completion date above is the date OFEvaluate Progression Free Survival (PFS)
measured Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Overall Survival (OS)
measured Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Objective Response Rate (ORR)
measured Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate Duration of Response (DOR)
measured From time of first response to the date of disease progression or death, up to 2 years
Evaluate Disease Control Rate (DCR)
measured Cycle 1 Day 1 through End of Study, up to 2 years
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.
measured Cycle 1 Day 1 through End of Study, up to 2 years
Evaluate the CA-125 response rate (RR) per Gynecologic Cancer Intergroup (GCIC) CA-125 criteria.
measured Cycle 1 Day 1 through End of Study, up to 2 years
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