Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Epithelial Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum
In brief
This study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. After baseline biomarker assessment (tumor antigen expression), the program will select the most suitable dual-target pair for clinical testing. Participants will receive lymphodepleting chemotherapy followed by EB-DUALNK infusion and safety/response follow-up.
Key facts
- Study ID
- NCT07589543
- Run by
- Beijing Biotech
- People needed
- 42
- Starts
- 2026-03-02
- Expected to finish
- 2028-03-17
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years; able to provide written informed consent.
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that is recurrent or refractory after standard therapy (at least 2 prior systemic regimens), with measurable disease per RECIST v1.1 and ECOG performance status 0-1.
- Tumor tissue available for antigen assessment. Participant must meet protocol-defined positivity for the selected dual-target pair (example: 1 target expressed in >=50% of tumor cells by IHC and the second target in >=20%).
- Adequate organ function per protocol-specified labs; negative pregnancy test nd agrees to use effective contraception for a protocol-defined period after infusion.
You may not qualify if…
- Active CNS metastases or carcinomatous meningitis (unless treated and stable for a protocol-defined period).
- Prior gene-modified cell therapy targeting any of the study antigens (GD2, MUC1, PSMA, mesothelin) within 6 months.
- Uncontrolled active infection (including uncontrolled HIV, HBV, or HCV) or active systemic fungal infection.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia) or LVEF <50% .
- Active autoimmune disease requiring systemic immunosuppression within 14 days prior to lymphodepletion (physiologic steroid replacement permitted).
- History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's judgment, would compromise participant safety or compliance.
Where it is running
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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