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NOT YET RECRUITING
NCT07532746
PHASE1

A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies

Sponsor: Kousai Bio Co., Ltd.

View on ClinicalTrials.gov

Summary

The main purpse of this study is to evaluate the safety and tolerability of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies,to preliminarily explore the clinical efficacy ,evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated hematological diseases and the improvement in subjects' quality of life (QOL) after KSD-101 treatment.

Official title: A Single-arm, Open-label, Multi-center Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies

Key Details

Gender

All

Age Range

2 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-05-01

Completion Date

2029-12-31

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

KSD-101

Patients will receive DC vaccine via subcutaneous injections bi-weekly,total 3-5 times. KSD-101 treatment dose: The dose is tentatively set at 2.5 or 5.0 × 10\^6 cells/dose in the adult cohort.

Locations (2)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China