NCT07589543 Dual-Target CAR-NK Cells in Recurrent or Refractory Epithelial Ovarian Cancer
| NCT ID | NCT07589543 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Biotech |
| Condition | Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07589543 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07589543 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07589543 currently recruiting?
Yes, NCT07589543 is actively recruiting participants. Contact the research team at Seni-Lu@beijing-biotech.com for enrollment information.
Where is the NCT07589543 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07589543 clinical trial?
NCT07589543 is sponsored by Beijing Biotech. The trial plans to enroll 42 participants.
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