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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Understand and voluntarily sign the informed consent form.

• Age 18 - 75 years (both 18 and 75 years), both sexes

• Expected survival of ≥ 12 weeks.

• Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to 1.

• B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology

• Patients with non-Hodgkin's lymphoma must have measurable lesions that meet the Lugano 2014 criteria for lymphoma efficacy assessment, requiring lymph node lesions \>1.5 cm in either length or extra-nodal lesions \>1.0 cm in either length.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhihao Jiang
zhihao_jiang@junshipharma.com
86-15350403639
Time Frame
Start Date: 2023-02-13
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 219
Treatments
Experimental: JS203
Related Therapeutic Areas
Sponsors
Leads: Shanghai Junshi Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov