NCT05618327

Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. The study is divided into three phases: a dose-escalation phase, a dose-expansion phase, and an efficacy expansion phase.

Conditions

• Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	JS203 for Injection	2-steps:JS203 for Injection is administered on the first and eighth day of the first cycle and every 3 weeks thereafter. 3-steps:JS203 for Injection is administered on the first, eighth and fifteenth day of the first cycle and every 3 weeks thereafter. 4-steps:JS203 for Injection is administered on the first, eighth, fifteenth and twenty-second day of the first cycle and every 3 weeks thereafter.

Timeline

• Start date: 2023-02-13
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2022-11-16
• Last updated: 2025-12-02

Locations

1 site across 1 country: China