Actively Recruiting
Exploratory Clinical Study on the Safety of STR-P004
Led by Beijing GoBroad Hospital · Updated on 2026-03-09
39
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
B
Beijing GoBroad Hospital
Lead Sponsor
S
Starna Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Clinical Study on the Safety of STR-P004
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial purpose and agree to participate by signing consent
- Age 18 years or older, any gender
- Diagnosed with systemic lupus erythematosus (SLE) by accepted criteria
- For SLE-ITP: platelet count below 50 x10^9/L in 2 tests, no other causes of thrombocytopenia, and prior treatment failure
- For other SLE: active disease despite standard treatment with stable doses for at least 30 days
- Diagnosed with possible or definite idiopathic inflammatory myopathies (IIM) meeting refractory or relapsed definitions
- For refractory IIM: stable immunosuppressant use with worsening disease despite glucocorticoid therapy
- For relapsed IIM: disease recurrence after remission needing increased treatment
You will not qualify if you...
- Severe lupus nephritis or need for dialysis within 8 weeks before screening
- Central nervous system diseases caused by SLE or other causes within 8 weeks
- Other types of inflammatory myopathies like inclusion body myositis or severe muscle damage unrelated to IIM
- SSc-related pulmonary hypertension requiring treatment or severe gastrointestinal involvement
- History of major organ or stem cell transplantation
- Multiple immune diseases requiring systemic treatment deemed unsuitable
- IgA deficiency with serum IgA below 10 mg/dL
- Participation in another clinical trial within 4 weeks or within 5 drug half-lives
- Prior CAR-T or gene therapy
- Recent use of specific immune-targeting drugs within defined timeframes
- Receipt of live or attenuated vaccine within 4 weeks or planned during the trial
- Uncontrolled active infection
- History of illicit drug use or alcoholism
- Recent major or minor surgery without full wound healing
- Recent serious cardiovascular disease within 6 months
- Severe underlying or mental diseases interfering with study participation
- Recent malignant tumors within 5 years except certain treated localized cancers
- Pregnant or breastfeeding women
- Positive tests for HIV, hepatitis B or C, or syphilis
- Active or latent tuberculosis at screening
- Splenectomy within 6 months before screening
- Other conditions making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, China
Actively Recruiting
Research Team
M
Miao shaocong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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