Epithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaRecurrent or Refractory Disease After Standard Therapies
Investigational drug(s) / intervention(s)
Dual-target CAR-NK cell productLymphodepleting chemotherapyStandard supportive care
Dual-target CAR-NK cell product: (Arm-specific)
Lymphodepleting chemotherapy: (cyclophosphamide and fludarabine)
Standard supportive care: antimicrobial prophylaxis per institutional practice
Study summary
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. At screening, each participant's tumor is assessed for expression of Mesothelin (MSLN), Folate Receptor alpha (FRalpha/FOLR1), and MUC16 (CA 125). Participants are assigned to the dual-target CAR-NK product that best matches their tumor antigen profile to reduce the risk of antigen escape.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (high-grade serous preferred).
* Recurrent or refractory disease after at least 2 prior systemic treatment lines (including a platinum-based regimen unless contraindicated).
* Measurable disease per RECIST v1.1.
* Tumor expresses at least two of the following targets above protocol-defined threshold: MSLN, FRalpha (FOLR1), MUC16 (CA 125) (archival or fresh biopsy).
* ECOG performance status 0-1.
* Adequate organ function (example): ANC \>= 1.0 x 10\^9/L; platelets \>= 75 x 10\^9/L; hemoglobin \>= 8 g/dL; AST/ALT \<= 3 x ULN (\<= 5 x ULN with liver metastases); total bilirubin \<= 1.5 x ULN; creatinine clearance \>= 50 mL/min.
* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception through 12 months post-infusion (or per local gene-therapy guidance).
* Able to comply with study procedures and follow-up schedule; written informed consent.
Exclusion Criteria:
* Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 6 months (or any prior therapy directed to the same target, per protocol).
* Active central nervous system (CNS) metastases or carcinomatous meningitis requiring therapy.
* Uncontrolled infection, including active tuberculosis; or clinically significant, uncontrolled viral infection.
* Known HIV infection with uncontrolled viremia; active hepatitis B or hepatitis C with detectable viral load (testing required at screening).
* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA Class III/IV heart failure).
* Active autoimmune disease requiring systemic immunosuppression within 30 days (physiologic steroid replacement allowed).
* Concurrent anti-cancer therapy (chemotherapy, targeted therapy, radiotherapy) not permitted within a protocol-defined washout period.
* Major surgery within 4 weeks prior to lymphodepletion (except minor procedures).
Primary outcome measure(s)
Incidence of dose-limiting toxicities (DLTs) — 28 Days
Incidence and severity of treatment-emergent adverse events — 12 months Incidence and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 (including CRS and ICANS)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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