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 (NCT06710288)
A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Chan Soon-Shiong Institute for Medicine — El Segundo, California
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Chan Soon-Shiong Institute for Medicine — El Segundo, California
- Hoag — Newport Beach, California
📞 Contact the Study Coordinator
Phone: (310) 912-2230
Email: jayson.garmizo@immunitybio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Platinum-resistant Ovarian Cancer
- Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1) — Phoenix, Arizona
- Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer — Anchorage, Alaska
- A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors — Little Rock, Arkansas
- Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer — Boston, Massachusetts
- Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) — Mobile, Alabama
Explore by condition: All Platinum-resistant Ovarian Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.