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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV). Participants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment. Participants who complete the study treatment or discontinue study treatment will be followed for survival/disease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 85 lat.
- •Zrozumienie i podpisanie świadomej zgody na udział w badaniu.
- •Lekarz prowadzący uzna, że pacjentka jest odpowiednia do dalszego leczenia tymi lekami.
- •Pacjentka otrzymała wcześniej leczenie bewacyzumabem.
- •Potwierdzony rak jajnika (nabłonkowy, wysokiego stopnia złośliwości) lub rak otrzewnej/jajowodu, który nie reaguje na leki zawierające platynę (nawrót w ciągu 6 miesięcy od leczenia platyną).
- •Widoczna zmiana chorobowa widoczna w badaniach obrazowych.
- •Pacjentka otrzymała od jednego do trzech wcześniejszych schematów leczenia przeciwnowotworowego i choroba postępowała mimo leczenia.
- •Pacjentka z mutacjami BRCA1 lub BRCA2 musiała otrzymać wcześniej lek z grupy inhibitorów PARP.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Last updated (source)
- July 1, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (2)
Chan Soon-Shiong Institute for Medicine
El Segundo, United States
Hoag
Newport Beach, United States
Trial contact
Jayson Garmizo
Kamin Personett
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.