Actively Recruiting
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
Led by ImmunityBio, Inc. · Updated on 2025-10-20
20
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and less than 85 years old
- Able to understand and sign informed consent per IRB or IEC guidelines
- Suitable for single-agent therapy as next treatment
- Prior treatment with bevacizumab
- Confirmed diagnosis of platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal or fallopian tube
- At least one measurable lesion by RECIST v1.1 criteria
- Received 1 to 3 prior systemic anticancer therapies with progression during or soon after last therapy
- Participants with BRCA1 or BRCA2 mutations must have had prior PARP inhibitor therapy
- Adequate peripheral venous access or willingness for temporary vascular access for apheresis
- Able to sit or recline with limited movement for about 6 hours during apheresis
- Tested for FR; if positive, offered treatment with mirvetuximab soravtansine-gynx
- Women of childbearing potential agree to effective contraception during and for 7 months after study
- ECOG performance status of 0 or 1
- Major surgery completed and recovered at least 4 weeks before first study dose
- Adequate organ and marrow function as specified
- Prior malignancies allowed if not interfering with study and treated
- Cardiac function class 2B or better by NYHA criteria
- Expected survival longer than 16 weeks
- Willing to comply with study procedures and attend required visits
You will not qualify if you...
- Clear cell, mucinous, sarcomatous histology, mixed tumors with these, or low grade/borderline ovarian tumors
- Distant metastasis outside the abdominopelvic cavity
- Anti-tumor chemotherapy or investigational agents within 2 weeks prior to M-CENK infusion, immunotherapy within 4 weeks prior, or unresolved adverse events
- Current or history of bowel obstruction or high risk for it
- Poor oral intake requiring parenteral nutrition or intravenous fluids
- Presence or history of ascites
- Receiving other investigational agents
- Solid organ transplant recipients
- Active progressing malignancy or other malignancy within 2 years except certain cured cancers
- Allergy to sulfa-containing medications or dimethyl sulfoxide (DMSO)
- Prior immune-related toxicity causing therapy discontinuation or requiring intense immunosuppression
- Autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, systemic sclerosis, lupus, vasculitis, or motor neuropathies of autoimmune origin
- Systemic corticosteroid therapy over 10 mg prednisone or equivalent for at least 4 weeks before NK cell infusion
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- HIV positive status
- Active uncontrolled hepatitis B or C, history of pneumonitis or interstitial lung disease
- Receipt of live vaccine within 30 days before study treatment start
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245
Actively Recruiting
2
Hoag
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
J
Jayson Garmizo
CONTACT
K
Kamin Personett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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