Dual-target CAR-NK therapy for recurrent ovarian, fallopian tube, or primary peritoneal cancer
Official title: A Phase 1/2, Open-Label, Biomarker-Assigned Study of Dual-Targeting CAR-NK Cells Directed Against Mesothelin (MSLN), Folate Receptor Alpha (FRα/FOLR1), and/or MUC16 (CA125) in Patients With Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Run by Beijing Biotech · NCT07480954 · Data updated 2026-11-12
This trial tests whether dual-target CAR‑NK cells can shrink tumors in people with recurrent or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors express at least two of MSLN, FRα, or MUC16.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 36 (estimated) |
| Sponsor | Beijing Biotech Industry-sponsored |
| Drugs / interventions | CAR-T, chemotherapy, chimeric antigen receptor, cyclophosphamide, fludarabine |
| Locations | 1 site (Shenzhen, Guangdong) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | February 17, 2027 |
| Study ends | May 17, 2028 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07480954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that has recurred after at least two prior systemic treatment lines and whose tumor expresses at least two of MSLN, FRα, or MUC16, with ECOG 0–1 and adequate organ function.
✕Probably not a fit
Patients whose tumors express fewer than two of the specified targets, who have poor performance status, or who cannot tolerate lymphodepleting chemotherapy are unlikely to benefit from this therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 trial enrolls patients with recurrent or refractory epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and assigns them to a dual-target CAR‑NK product matched to their tumor antigen profile. Part 1 uses a 3+3 dose-escalation design within each antigen-pair cohort to determine safety and a recommended Phase 2 dose, and Part 2 is a dose-expansion cohort at the RP2D to explore preliminary efficacy and biomarkers. Tumors are tested by IHC and/or flow cytometry to confirm expression of at least two targets (MSLN, FRα, MUC16) before assignment. Patients receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by CAR‑NK infusion, typically given intraperitoneally via an implanted port with optional IV dosing, and are monitored for CRS, neurotoxicity, cytopenias, infections, and response by RECIST v1.1 with CA‑125 trends as supportive data.
Why it matters
Potential benefit: If successful, this approach could deliver a targeted cell therapy that produces deeper and more durable tumor responses for antigen-positive recurrent ovarian cancer.
How similar studies have gone: Early-phase work with CAR‑NK and CAR‑T approaches in other cancers has shown encouraging signals of safety and occasional responses, but dual‑target CAR‑NK therapy for ovarian cancer is largely novel with limited prior human data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.