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Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) pt2

ConditionsEpithelial Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CarcinomaRecurrent or Refractory Disease After Standard Therapies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorBeijing Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dual-target CAR-NK cell product

    Biological/Vaccine

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

  • Cyclophosphamide

    Drug

    Cyclophosphamide + Fludarabine lymphodepletion

  • supportive

    Other intervention

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

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: EB-NK-MFExperimental treatment 3 interventions
Group B: EB-NK-MMExperimental treatment 3 interventions
Group C: EB-NK-FMExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 Days
2

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

Time frame
12 months

Secondary outcomes

1

Objective response rate (ORR) by RECIST v1.1

Time frame
6 months
2

Duration of response (DOR) among responders

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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