RecruitingPhase 1Phase 2NCT06841042

A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus

Sponsor

Sinocelltech Ltd.

Enrollment

168 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

System Lupus Erythematosus

Summary

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called SCTB35 injection for people with system lupus erythematosus. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSCTB35 injection

SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTB35 will be applied for the dose-expansion cohorts.

Locations(14)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Xuanwu Hospital, Capital Medical University

Beijing, China

Jilin Provincial People's Hospital

Changchun, China

Guangdong Provincial People's Hospital

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

The First People's Hospital of Jiujiang City

Jiujiang, China

The First Affiliated Hospital of Kunming Medical University

Kunming, China

Linfen Central Hospital

Linfen, China

Mianyang Central Hospital

Mianyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Pingxiang People's Hospital

Pingxiang, China

Shanxi Bethune Hospital

Taiyuan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Xinxiang Central Hospital

Xinxiang, China

View Full Details on ClinicalTrials.gov

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NCT06841042