NCT07617753

Brief Summary

This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. At screening, each participant's tumor is assessed for expression of Mesothelin (MSLN), Folate Receptor alpha (FRalpha/FOLR1), and MUC16 (CA 125). Participants are assigned to the dual-target CAR-NK product that best matches their tumor antigen profile to reduce the risk of antigen escape.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
20mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 2, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2028

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Epithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaRecurrent or Refractory Disease After Standard Therapies

Keywords

CAR-NKDual targetingMesothelin (MSLN)Folate Receptor alphaMUC16Intraperitoneal administrationAdoptive cell therapyOvarian cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of dose-limiting toxicities (DLTs)

    28 Days

  • Incidence and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0

    12 months

Secondary Outcomes (2)

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

    6 months

  • Duration of response (DOR) among responders

    12 months

Study Arms (3)

EB-NK-MF

EXPERIMENTAL

Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and Folate Receptor alpha (FRalpha/FOLR1). Assigned to participants whose tumors express MSLN and FRalpha above threshold

Biological: Dual-target CAR-NK cell productDrug: CyclophosphamideOther: supportive

EB-NK-MM

EXPERIMENTAL

Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and MUC16 (CA 125). Assigned to participants whose tumors express MSLN and MUC16 above threshold.

Biological: Dual-target CAR-NK cell productDrug: CyclophosphamideOther: supportive

EB-NK-FM

EXPERIMENTAL

Dual-target CAR-NK cells recognizing FRalpha (FOLR1) and MUC16 (CA 125). Assigned to participants whose tumors express FRalpha and MUC16 above threshold.

Biological: Dual-target CAR-NK cell productDrug: CyclophosphamideOther: supportive

Interventions

Dual-target CAR-NK cell productBIOLOGICAL

EB-NK-MF CAR-NK cells (dose levels 1-3)

EB-NK-FMEB-NK-MFEB-NK-MM
CyclophosphamideDRUG

Cyclophosphamide + Fludarabine lymphodepletion

EB-NK-FMEB-NK-MFEB-NK-MM
supportiveOTHER

Standard supportive care (e.g., antimicrobial prophylaxis) per institutional practice.

EB-NK-FMEB-NK-MFEB-NK-MM

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (high-grade serous preferred).
  • Recurrent or refractory disease after at least 2 prior systemic treatment lines (including a platinum-based regimen unless contraindicated).
  • Measurable disease per RECIST v1.1.
  • Tumor expresses at least two of the following targets above protocol-defined threshold: MSLN, FRalpha (FOLR1), MUC16 (CA 125) (archival or fresh biopsy).
  • ECOG performance status 0-1.
  • Adequate organ function : ANC \>= 1.0 x 10\^9/L; platelets \>= 75 x 10\^9/L; hemoglobin \>= 8 g/dL; AST/ALT \<= 3 x ULN (\<= 5 x ULN with liver metastases); total bilirubin \<= 1.5 x ULN; creatinine clearance \>= 50 mL/min.
  • Negative pregnancy test for women of childbearing potential; agreement to use effective contraception through 12 months post-infusion (or per local gene-therapy guidance).
  • Able to comply with study procedures and follow-up schedule; written informed consent.

You may not qualify if:

  • Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 6 months (or any prior therapy directed to the same target, per protocol).
  • Active central nervous system (CNS) metastases or carcinomatous meningitis requiring therapy.
  • Uncontrolled infection, including active tuberculosis; or clinically significant, uncontrolled viral infection.
  • Known HIV infection with uncontrolled viremia; active hepatitis B or hepatitis C with detectable viral load (testing required at screening).
  • Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA Class III/IV heart failure).
  • Active autoimmune disease requiring systemic immunosuppression within 30 days (physiologic steroid replacement allowed).
  • Concurrent anti-cancer therapy (chemotherapy, targeted therapy, radiotherapy) not permitted within a protocol-defined washout period.
  • Major surgery within 4 weeks prior to lymphodepletion (except minor procedures)
  • Pregnant or breastfeeding.
  • Any condition that, in the investigator's judgment, would increase risk (e.g., severe pulmonary disease) or interfere with study interpretation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsRecurrenceOvarian Neoplasms

Interventions

CyclophosphamidePalliative Care

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Seni S Lu, Phd

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned (non-randomized) to one of three dual-target CAR-NK products based on tumor antigen expression (MSLN/FRalpha, MSLN/MUC16, or FRalpha/MUC16). Dose escalation proceeds within each cohort; an expansion stage enrolls additional participants at the RP2D.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

June 14, 2027

Study Completion (Estimated)

March 17, 2028

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations

CN(1)