NCT07143617

Exploratory Clinical Study on the Safety of STR-P004

Exploratory Clinical Study on the Safety of STR-P004 in the Treatment of Patients With Relapsed or Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases.

Detailed description

This study adopts the "TITE-BOIN12" dose escalation design. Two TITE-BOIN12 dose exploration cohorts (SLE-ITP and SLE-Other) are planned. Dose escalation and OBD selection decisions for the SLE-ITP and SLE-Other subject cohorts will be made independently based on the safety and efficacy data from their respective cohorts. Dose escalation/de-escalation and OBD decisions for the two cohorts are independent of each other. Subjects with other indications will only be enrolled at dose levels confirmed as safe by the SLE-ITP and SLE-Other cohorts (i.e., based on the DLT rate of the current dose group, where the dose escalation/de-escalation decision is not to de-escalate) and will not participate in the dose escalation or OBD selection decisions. This study plans to include three dose groups: DL-1 xx mg/kg, DL1 xx mg/kg, and DL2 xx mg/kg. DL-1 is the backup de-escalation dose group, and the starting dose group is DL1. If one or more DLTs occur among the first three subjects enrolled in DL1 (regardless of cohort, i.e., when the total number of SLE-ITP and SLE-Other subjects enrolled in DL1 reaches three), all cohorts will de-escalate to the backup dose group, and the TITE-BOIN12 dose escalation and expansion strategy will be implemented starting from the DL-1 dose group.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	STR-P004	STR-P004 Intravenous infusion

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-08-15
• Completion: 2026-09-14
• First posted: 2025-08-27
• Last updated: 2026-03-09

Locations

1 site across 1 country: China