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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase study that uses a biomarker-driven approach to select a dual-target CAR-NK cell therapy (EB-DUALNK) tailored to the patient's tumor antigen profile. After baseline antigen testing, the most suitable pair of targets will be chosen and EB-DUALNK will be given after lymphodepleting chemotherapy, with safety and preliminary efficacy monitored. The trial includes a dose-escalation phase to identify a recommended dose for expansion and will assess safety endpoints such as CRS and ICANS, as well as anti-tumor activity by imaging and CA-125 where appropriate. Correlative studies will examine CAR-NK persistence, cellular phenotype, cytokine profiles, and relationships between antigen expression and outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: shan S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VT-101 in Advanced Ovarian Cancer: early safety study in adults

  This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.

  Recruiting Phase 1 University of Iowa · Iowa City, Iowa · NCT07905677

• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

  This trial tests whether adding torvu-samrotecan to bevacizumab after standard chemotherapy helps people with non-HRD advanced epithelial ovarian cancer live longer without the cancer worsening compared with bevacizumab alone.

  Recruiting at 4 sites Phase 3 AstraZeneca · Tamarac, Florida and 219 other locations · NCT07851025

• Whole-body metabolic activity as a predictor of chemotherapy response in epithelial ovarian cancer

  This study tests whether whole-body metabolic activity can predict how well epithelial ovarian cancer responds to chemotherapy.

  Recruiting University of Tennessee Graduate School of Medicine · Knoxville, Tennessee · NCT07764133

• [68Ga]BED003 PET imaging to see fibroblast activity in selected cancers

  This study tests a PET imaging agent, [68Ga]BED003, to see how well it detects tumors in colorectal, gastric, pancreatic, ovarian, and invasive lobular breast cancers.

  Recruiting at 5 sites Phase 2 Blue Earth Diagnostics · Bergamo, Lombardy and 5 other locations · NCT07702292

• Dual-target CAR-NK Cells for Peritoneal Cancers of the Ovary, Fallopian Tube, or Pseudoperitoneal Disease

  This trial tests a dual-target CAR-NK cell therapy for people with recurrent or hard-to-treat epithelial ovarian, fallopian tube, or primary peritoneal cancer who express two or more specific tumor markers.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07617753

• Daphnetin plus TC chemotherapy and targeted maintenance after surgery for stage III–IV epithelial ovarian cancer

  This trial tests whether adding daphnetin capsules to standard paclitaxel‑carboplatin chemotherapy and then combining daphnetin with targeted maintenance can help people with stage III–IV epithelial ovarian cancer who had R0 or R1 surgery.

  Recruiting The First Hospital of Jilin University · Changchun, Jilin · NCT07495397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.