Health TrialsbyHealthPanel

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

ConditionsEpithelial Ovarian CancerEpithelial Ovarian Cancer, Fallopian Tube or Peritoneum
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBeijing Biotech

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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% .

Trial design

Design model

Single group

Treatments tested in this trial

  • EB-DUALNK

    Biological/Vaccine

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

  • Cyclophosphamide

    Drug

    lymphodepletion

  • Fludarabine

    Drug

    lymphodepletion

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: EB-DUALNK following lymphodepleting chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
28 days
2

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

Time frame
28 days

Secondary outcomes

1

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

Time frame
12 months
2

Overall survival (OS)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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