Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
FEMALE
NCT07480954

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

Led by Beijing Biotech · Updated on 2026-03-18

36

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 6 1.0 x 10^9/L; platelets 6 75 x 10^9/L; hemoglobin 6 8 g/dL; AST/ALT 4 x ULN (5 x ULN with liver metastases); total bilirubin 6 1.5 x ULN; creatinine clearance 6 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
Not Eligible

You will not qualify if you...

  • Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 6 months or any prior therapy directed to the same target
  • Active central nervous system 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
  • Clinically significant cardiovascular disease such as 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 not permitted within protocol-defined washout period
  • Major surgery within 4 weeks prior to lymphodepletion except minor procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

S

Seni S Lu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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