Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)

Recruiting now · Phase 1/Phase 2

Conditions studied: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Recurrent or Refractory Disease After Standard Therapies

In brief

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.

Key facts

Study ID

NCT07480954

Run by

Beijing Biotech

People needed

36

Starts

2026-02-04

Expected to finish

2028-05-17

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.