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RECRUITING
NCT07598955
PHASE1/PHASE2

Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

Summary

This Phase 1/2 study evaluates the safety, tolerability, and preliminary efficacy of target-selected CAR-natural killer (CAR-NK) cells in adults with relapsed or refractory B2 thymoma or thymic carcinoma. Participants undergo centralized tumor antigen assessment (CD30, CD5, and mesothelin). Based on the dominant and clinically actionable antigen expression profile, each participant is assigned to one of three parallel cohorts (CD30-CAR-NK, CD5-CAR-NK, or mesothelin-CAR-NK). All cohorts use the same lymphodepleting conditioning regimen followed by CAR-NK infusion(s).

Official title: A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-02

Completion Date

2028-04-17

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

lymphodepletion

DRUG

Fludarabine

lymphodepletion

BIOLOGICAL

EB-CAR30-NK

CD30-targeted allogeneic CAR-NK cells

BIOLOGICAL

EB-CAR5-NK

CD5-targeted allogeneic CAR-NK cells

BIOLOGICAL

EB-CARMSLN-NK

Mesothelin-targeted allogeneic CAR-NK cells

DRUG

Rimiducid (AP1903)

ctivate the iCasp9 safety switch if clinically indicated

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China