Dual-target CAR-NK Cells for Peritoneal Cancers of the Ovary, Fallopian Tube, or Pseudoperitoneal Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional study evaluating the safety, tolerability, and early signs of effectiveness of CAR-NK cells engineered to target two tumor antigens (MSLN, FRα, MUC16) in patients with recurrent or refractory peritoneal or ovarian cancers. Tumor tissue is screened to assign participants to the most appropriate dual-antigen CAR-NK product, aiming to reduce antigen escape. The trial uses a 3+3 dose-escalation design within antigen-pair cohorts to establish a recommended dose, followed by expansion at that dose to assess preliminary efficacy and biomarker data. CAR-NK administration is intraperitoneal via implanted port (with optional IV dosing), after lymphodepleting chemotherapy, with monitoring for cytokine release syndrome, neurotoxicity, cytopenias, infections, and other events. Response is tracked by RECIST v1.1 and CA-125 trends, with up to 24 months of survival follow-up.

Why it matters

Who can join: the full rules

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 : 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)
* Pregnant or breastfeeding.
* Any condition that, in the investigator's judgment, would increase risk (e.g., severe pulmonary disease) or interfere with study interpretation.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.