NCT07589543RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 10 May 2026
- Start date
- 2 Mar 2026
- Primary completion date
- 14 Mar 2027
- Lead sponsor
- Beijing Biotech
- Diseases
- Ovarian cancer
- NCT number
- NCT07589543
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 42
- From 2 Mar 2026 to the primary completion date, 14 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior gene-modified cell therapy targeting any of the study antigens (GD2, MUC1, PSMA, mesothelin) within 6 months.
- Active autoimmune disease requiring systemic immunosuppression within 14 days prior to lymphodepletion (physiologic steroid replacement permitted).
Other illness
- Uncontrolled active infection (including uncontrolled HIV, HBV, or HCV) or active systemic fungal infection.
- History of organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Any condition that, in the investigator's judgment, would compromise participant safety or compliance.
Lab values
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia) or LVEF \<50% .
Other
- Active CNS metastases or carcinomatous meningitis (unless treated and stable for a protocol-defined period).
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.