Actively Recruiting
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
Led by ImmunityBio, Inc. · Updated on 2025-10-20
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of a treatment combining M-CENK adoptive cell therapy, N-803, and gemcitabine in women with platinum-resistant high-grade ovarian cancer. This phase 2, open-label study involves participants who have had prior treatments and whose cancer has returned within six months after platinum-based chemotherapy. The study is sponsored by ImmunityBio, Inc. and seeks to understand how well this combination works and its impact on survival and disease progression. Participants will first undergo a procedure to collect mononuclear cells for manufacturing M-CENK. Starting from the first cycle, they will receive gemcitabine intravenously on days 1, 8, and 15 of each 4-week cycle. From the second cycle onward, participants will also receive M-CENK cells intravenously on day 1 of each cycle and N-803 subcutaneously on days 1 and 15. N-803 dosing continues with additional doses after the last M-CENK infusion. Treatment continues until no more M-CENK cells are available or disease progression is confirmed, unless the investigator sees ongoing benefit. During the study, participants will be monitored closely with regular assessments, including scans and laboratory tests, to track tumor response and side effects. Safety is evaluated through various blood panels and vital signs from screening through follow-up. After completing or stopping treatment, participants will be followed every 12 weeks for up to 12 months to monitor survival and disease status. The main outcomes measured include progression-free survival, overall survival, response rates, and duration of response over up to two years.
CONDITIONS
Brief 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...
- Age 18 to less than 85 years old
- Able to understand and provide signed informed consent
- Suitable for single-agent therapy as next treatment per Investigator
- Prior treatment with bevacizumab
- Confirmed diagnosis of platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer
- At least one measurable lesion by RECIST v1.1 criteria
- Received 1 to 3 prior systemic anticancer therapies with progressive disease during or after last therapy
- If BRCA1 or BRCA2 mutation positive, prior PARP inhibitor therapy received
- Adequate peripheral venous access or willing to have temporary vascular access for apheresis
- Able to sit or recline for about 6 hours during apheresis
- Previously tested for FRα and if positive, offered mirvetuximab soravtansine-gynx treatment
- Agreement to use effective contraception if of childbearing potential for up to 7 months after treatment
- ECOG performance status 0 or 1
- Major surgery completed and recovered at least 4 weeks before starting treatment
- Meets specific organ and marrow function requirements
- Prior malignancies allowed if they do not interfere with study
- Cardiac function assessed with NYHA class 2B or better
- Expected survival longer than 16 weeks
- Willingness to comply with study procedures and attend required visits
You will not qualify if you...
- Clear cell, mucinous, sarcomatous histology or low grade/borderline ovarian tumors
- Distant metastasis outside abdominopelvic cavity
- Anti-tumor chemotherapy or investigational agents within 2 weeks before M-CENK infusion or immunotherapy within 4 weeks
- Current or high risk of bowel obstruction
- Poor oral intake requiring parenteral nutrition or intravenous fluids
- Presence or history of ascites
- Receiving other investigational agents
- Solid organ transplant recipients
- Additional progressing malignancies or recent other cancers within 2 years except certain cured skin or non-invasive cancers
- Known allergy to sulfa-containing medications or dimethyl sulfoxide (DMSO)
- Prior immune-related toxicity causing permanent therapy discontinuation or requiring intensive immunosuppression except controlled endocrinopathy
- Autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, lupus, or autoimmune motor neuropathies (Hashimoto thyroiditis allowed)
- Systemic corticosteroids above 10 mg prednisone equivalent within 4 weeks before NK cell infusion
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- HIV positive
- Active uncontrolled hepatitis B or C, known pneumonitis or interstitial lung disease
- Receipt of live vaccine within 30 days before study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 4-week cycles as long as M-CENK cells are available and treatment continues.
Participants receive Gemcitabine intravenously on Day 1, 8, and 15 of each 4-week cycle; M-CENK cell therapy intravenously on Day 1 of each cycle while cells are available; and N-803 subcutaneously on Day 1 and 15 of each cycle starting at Cycle 2, with additional doses after the last M-CENK dose.
Visits on Day 1, 8, and 15 of each 4-week cycle
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
K
Kamin Personett
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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