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

NCT07589543 | Recruiting Phase 1 DMC

• 1 other identifier: EB-OVCA-DUALNK-118
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer; Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum

Keywords

Solid tumor; Ovarian cancer; Immunotherapy; Adoptive cell therapy; CAR-NK; Dual-target; GD2; MUC1; PSMA; Mesothelin

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLTs) to determine maximum tolerated dose (MTD)

  28 days

• Incidence, severity, and relatedness of adverse events (AEs)

  28 days

Secondary Outcomes (2)

• Objective response rate (ORR) per RECIST v1.1.

  12 months

• Overall survival (OS)

  12 months

Study Arms (1)

EB-DUALNK following lymphodepleting chemotherapy

EXPERIMENTAL

Biological: EB-DUALNK; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

EB-DUALNK BIOLOGICAL

(dual-target CAR-NK cells; selected antigen pair from GD2, MUC1, PSMA, mesothelin)

EB-DUALNK following lymphodepleting chemotherapy

Cyclophosphamide DRUG

lymphodepletion

EB-DUALNK following lymphodepleting chemotherapy

Fludarabine DRUG

lymphodepletion

EB-DUALNK following lymphodepleting chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beijing Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

shan S Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label: participants and investigators know the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Dose escalation (3+3 design) of EB-DUALNK after lymphodepletion to determine DLTs and RP2D. Part B: Dose expansion at RP2D to further characterize safety and estimate preliminary efficacy.

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 17, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)