Exploratory Clinical Study on the Safety of STR-P004

Sponsor
Beijing GoBroad Hospital
Study ID
NCT07143617
Status
Recruiting
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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STR-P004 — BIOLOGICAL
    STR-P004 Intravenous infusion

Study Details

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.

Key Dates

First listed
Aug 27, 2025
Start date
Sep 16, 2025
Status verified
Mar 2026
Primary completion
Aug 15, 2026
Completion
Sep 14, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DL-1 STR-P004 Amg/kg
    Enrolled patients will receive Amg/kg of STR-P004 Intravenous infusion
  • Experimental: DL1 STR-P004 Bmg/kg
    Enrolled patients will receive Bmg/kg of STR-P004 Intravenous infusion
  • Experimental: DL2 STR-P004 Cmg/kg
    Enrolled patients will receive Cmg/kg of STR-P004 Intravenous infusion

Primary Outcome Measure

Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs); [ Time Frame: 12 months ]

Central Contacts

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