RecruitingPhase 1Phase 2NCT07480954

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

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


Sponsor

Beijing Biotech

Enrollment

36 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-NK cell therapy — a cutting-edge immune cell treatment — for women with ovarian cancer that has come back or stopped responding to standard treatments. The engineered cells are designed to recognize and attack ovarian cancer cells by targeting multiple proteins found on their surface. **You may be eligible if...** - You have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer (especially high-grade serous type) - Your cancer has returned or stopped responding after at least 2 prior treatment regimens, including platinum-based chemotherapy - Your tumor tests positive for at least two of the following proteins: MSLN, FRalpha (FOLR1), or MUC16 - You are in good physical condition (ECOG 0–1) with adequate blood, liver, and kidney function - You are willing to use contraception for 12 months after treatment **You may NOT be eligible if...** - You received CAR-T or CAR-NK cell therapy in the past 6 months - Your cancer has spread to the brain - You have an uncontrolled infection, active tuberculosis, or uncontrolled HIV/hepatitis - You have serious heart disease or active autoimmune disease requiring medication - You had major surgery in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDual-target CAR-NK cell product

(Arm-specific)

DRUGLymphodepleting chemotherapy

(cyclophosphamide and fludarabine)

OTHERStandard supportive care

antimicrobial prophylaxis per institutional practice


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07480954


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