Phase 2 Study of M-CENK Cell Therapy and N-803 with Gemcitabine for Recurrent Platinum-Resistant High-Grade Ovarian Cancer

Inclusion Criteria

• Aged between 18 and 84 years.
• Able to understand and sign a consent form.
• Suitable for single-agent therapy as the next treatment step.
• Previously treated with bevacizumab.
• Diagnosed with platinum-resistant high-grade ovarian cancer, primary peritoneal, or fallopian tube cancer.
• Must have at least one measurable tumor.
• Received 1 to 3 prior cancer treatments and had disease progression.
• If having BRCA mutations, must have had prior PARP inhibitor therapy.
• Must have good vein access or be willing to have temporary access for cell collection.
• Able to sit or recline for about 6 hours during cell collection.
• Tested for FRα and offered specific treatment if positive.
• Agree to use effective contraception if of childbearing potential.
• ECOG performance status of 0 or 1.
• Major surgery completed and recovered at least 4 weeks before starting treatment.
• Meet specific blood and organ function criteria.
• No other active or progressing cancers that interfere with the study.
• Cardiac function assessed and classified as class 2B or better.
• Expected to live more than 16 weeks.
• Willing to follow study procedures and attend follow-up visits.

Exclusion Criteria

• Have certain types of ovarian cancer or mixed tumors.
• Cancer spread outside the abdomen and pelvis.
• Recent chemotherapy or investigational drugs within specified timeframes.
• Current or high risk of bowel obstruction.
• Poor oral intake requiring special nutrition.
• Presence or history of fluid buildup in the abdomen.
• Receiving other investigational treatments.
• Have had an organ transplant.
• Other active cancers needing treatment or recent cancer history, except for certain skin or non-invasive cancers.
• Allergic to study medications or their components.
• History of severe immune-related side effects from previous treatments.
• Autoimmune diseases, except for well-controlled thyroiditis.
• Recent use of high-dose steroids.
• Uncontrolled illnesses or infections.
• HIV-positive or active hepatitis B or C.
• Recent live vaccine within 30 days of starting treatment.