RecruitingPhase 1Phase 2NCT07589543

Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer

A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of Dual-Target CAR-NK Cells (EB-DUALNK) Following Lymphodepleting Chemotherapy in Adults With Recurrent or Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Sponsor

Beijing Biotech

Enrollment

42 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Epithelial Ovarian Cancer Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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.

Exclusion Criteria8

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.