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Clinical Trial NCT07480954 (DUAL-OV-CAR-NK) for Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Recurrent or Refractory Disease After Standard Therapies is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) (DUAL-OV-CAR-NK) Phase 1, Phase 2 36
Clinical Trial NCT07480954 (DUAL-OV-CAR-NK) is designed to study Treatment for Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Recurrent or Refractory Disease After Standard Therapies. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 4 February 2026, with plans to enroll 36 participants. Led by Beijing Biotech, it is expected to complete by 17 May 2028. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
Brief 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 1...Show More
Detailed Description
The study has two parts: (1) dose escalation using a standard 3+3 design within each antigen-pair cohort to determine safety and a recommended Phase 2 dose (RP2D), and (2) dose expansion at the RP2D to explore preliminary efficacy and translational biomarkers. Target selection (biomarker assignment): Tumor tissue (archival or fresh biopsy) is evaluated by immunohistochemistry (IHC) and/or flow cytometry for MSLN, FRa...Show More
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
Conditions
Epithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaRecurrent or Refractory Disease After Standard TherapiesOther Study IDs
- DUAL-OV-CAR-NK
- EB-CARNK-OV-101
NCT ID Number
Start Date (Actual)
2026-02-04
Last Update Posted
2026-03-18
Completion Date (Estimated)
2028-05-17
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
CAR-NK
Dual targeting
Mesothelin (MSLN)
Folate Receptor alpha
MUC16 (CA 125)
Intraperitoneal administration
Adoptive cell therapy
Ovarian cancer
Dual targeting
Mesothelin (MSLN)
Folate Receptor alpha
MUC16 (CA 125)
Intraperitoneal administration
Adoptive cell therapy
Ovarian cancer
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEB-NK-MF (MSLN/FRalpha) Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and Folate Receptor alpha (FRalpha/FOLR1). Assigned to participants whose tumors express MSLN and FRalpha above threshold. | Dual-target CAR-NK cell product (Arm-specific) Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
ExperimentalEB-NK-MM (MSLN/MUC16) Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and MUC16 (CA 125). Assigned to participants whose tumors express MSLN and MUC16 above threshold. | Dual-target CAR-NK cell product (Arm-specific) Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
ExperimentalEB-NK-FM (FRalpha/MUC16) Dual-target CAR-NK cells recognizing FRalpha (FOLR1) and MUC16 (CA 125). Assigned to participants whose tumors express FRalpha and MUC16 above threshold. | Dual-target CAR-NK cell product (Arm-specific) Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of dose-limiting toxicities (DLTs) | 28 Days | |
Incidence and severity of treatment-emergent adverse events | Incidence and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 (including CRS and ICANS) | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective response rate (ORR) | Objective response rate (ORR) by RECIST v1.1 (CR + PR) | 6 months |
Duration of response (DOR) among responders | 12 months | |
Progression-free survival (PFS) | 12 months | |
Overall survival (OS) | 24 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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).
Beijing BiotechStudy Central Contact
Contact: Seni S Lu, Phd, +86 13076790030, [email protected]
1 Study Locations in 1 Countries
Guangdong
Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, Contact, +8613076790039, [email protected]
Recruiting