Epithelial Ovarian CancerPhase 1/2DUAL-OV-CAR-NKNCT07480954
Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)
A Phase 1/2 study testing Dual-target CAR-NK cell product, Lymphodepleting chemotherapy and Standard supportive care in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by Beijing Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma
- What is being tested?
- Dual-target CAR-NK cell product, Lymphodepleting chemotherapy and Standard supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2026to 17 May 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +8613076790039, Zhen-Peng@beijing-biotech.com
About this study
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
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.
Read the 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, FRalpha, and MUC16. Eligibility requires expression of at least two of the three targets above a pre-specified threshold. If all three are positive, a Target Selection Committee assigns the participant to the dual-target pair with the highest combined expression (e.g., H-score or percent positive cells) and acceptable normal-tissue risk.
Treatment schema: Participants receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by CAR-NK administration. In this example, CAR-NK cells are given intraperitoneally via an implanted port to maximize exposure to peritoneal disease, with optional intravenous dosing per investigator judgment. Participants are monitored closely for cytokine release syndrome (CRS), neurotoxicity (ICANS), cytopenias, infections, and other adverse events.
Response assessments are performed by RECIST v1.1 at regular intervals, with CA 125 trends collected as supportive disease activity data. Follow-up: Participants are followed for adverse events through 12 months and for survival for up to 24 months. Long-term follow-up for gene-modified cell therapy safety may be required per local regulations.
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Carcinoma, Recurrent or Refractory Disease After Standard Therapies
- Being tested
- Dual-target CAR-NK cell product, Lymphodepleting chemotherapy, Standard supportive care
- Keywords
- CAR-NK, Dual targeting, Mesothelin (MSLN), Folate Receptor alpha, MUC16 (CA 125), Intraperitoneal administration, Adoptive cell therapy, Ovarian cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Recurrence, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-target CAR-NK cell productBiological
(Arm-specific)
Lymphodepleting chemotherapyDrug
(cyclophosphamide and fludarabine)
Standard supportive careOther
antimicrobial prophylaxis per institutional practice
| Study group | Role | What they receive |
|---|---|---|
| EB-NK-MF (MSLN/FRalpha) | Experimental | 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. Receives: Biological: Dual-target CAR-NK cell product; Drug: Lymphodepleting chemotherapy; Other: Standard supportive care |
| EB-NK-MM (MSLN/MUC16) | Experimental | Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and MUC16 (CA 125). Assigned to participants whose tumors express MSLN and MUC16 above threshold. Receives: Biological: Dual-target CAR-NK cell product; Drug: Lymphodepleting chemotherapy; Other: Standard supportive care |
| EB-NK-FM (FRalpha/MUC16) | Experimental | Dual-target CAR-NK cells recognizing FRalpha (FOLR1) and MUC16 (CA 125). Assigned to participants whose tumors express FRalpha and MUC16 above threshold. Receives: Biological: Dual-target CAR-NK cell product; Drug: Lymphodepleting chemotherapy; Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: 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)
Measured: 12 months
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR) by RECIST v1.1 (CR + PR)
Measured: 6 months
Duration of response (DOR) among responders
Measured: 12 months
Progression-free survival (PFS)
Measured: 12 months
Overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start4 Feb 2026
- Primary completion17 Feb 2027 (estimated)
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned (non-randomized) to one of three dual-target CAR-NK products based on tumor antigen expression (MSLN/FRalpha, MSLN/MUC16, or FRalpha/MUC16). Dose escalation proceeds within each cohort; an expansion stage enrolls additional participants at the RP2D.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480954
- Sponsor's protocol ID
- EB-CARNK-OV-101
- Acronym
- DUAL-OV-CAR-NK
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No