NCT06058091

RY_SW01 Cell Injection Therapy in Systemic Sclerosis

A Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of RY_SW01 Cell Injection Therapy in Systemic Sclerosis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Jiangsu Renocell Biotech Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.

Detailed description

This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I dose-escalation stage adopts a single-arm trial design, aiming to explore the safety, tolerability, and preliminary efficacy of RY\_SW01 cell injection in treating patients with systemic sclerosis. The Phase II dose-expansion stage adopts a randomized, double-blind controlled trial design, intending to explore the safety, efficacy, and changes in disease-related biomarkers of RY\_SW01 cell injection in treating systemic sclerosis patients. Based on the characteristics of this product and pre-clinical study data, as well as integrating the safety and efficacy data of similar types of drugs and clinical trials for the same or similar indications published domestically and internationally, the researchers and sponsors jointly selected the trial exploration doses as low dose 1.0×10\^6 cells/kg and high dose 2.0×10\^6 cells/kg. The trial will enroll systemic sclerosis patients aged ≥18 and ≤65 years, who must meet all inclusion criteria and none of the exclusion criteria. Approximately 81-87 subjects are planned to be enrolled to undergo dose-escalation and dose-expansion trials with RY\_SW01 cell injection. The dose-escalation stage plans to enroll 6-12 evaluable subjects, and the dose-expansion stage plans to enroll 75 subjects.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	RY_SW01 cell injection	Administer basic treatment with an injection of RY\_SW01 cell solution
DRUG	Basic treatment	Basic treatment for SSc

Timeline

• Start date: 2023-09-22
• Primary completion: 2025-12-31
• Completion: 2035-12-31
• First posted: 2023-09-28
• Last updated: 2024-01-18

Locations

1 site across 1 country: China