Exploratory Clinical Study on the Safety of STR-P004

ConditionAutoimmune Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeijing GoBroad Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the purpose, nature, method of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.

Aged ≥18 years (including the boundary value, based on the time of signing the informed consent form), male or female;

Diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/1997 American College of Rheumatology (ACR) classification criteria for diagnosis.

SLE-ITP: platelet count < 50×10^9/L in at least 2 consecutive blood routine tests; no obvious abnormalities in blood cell morphology by peripheral blood smear microscopy; bone marrow cell morphology consistent with immune thrombocytopenia; excluding thrombocytopenia caused by other non-SLE reasons, such as infection, bone marrow suppression, splenomegaly, hypersplenism, etc.; failed to achieve at least partial response after receiving at least 1 course of MP pulse therapy (1g×3 days) or high-dose hormone (1mg/kg/d equivalent glucocorticoid) combined with 1 or more immunosuppressants. Note: Complete Response (CR): platelet count ≥100×10^9/L; Partial Response (PR): platelet count 30-100×10^9/L, at least twice the pre-treatment level, and no bleeding.

Disqualifiers

Severe lupus nephritis within 8 weeks before screening (defined as urinary protein >6 g/24 hours or serum creatinine >2.5 mg/dL or 221 μmol/L), or need to use protocol-prohibited drugs to treat active nephritis, or need hemodialysis or receive prednisone ≥100 mg/d or equivalent glucocorticoid treatment for ≥14 days;

Central nervous system diseases caused by SLE or non-SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.);

Other types of idiopathic inflammatory myopathies: inclusion body myositis, atrophic diabetes, juvenile myositis; patients with severe muscle damage or myositis with permanent weakness or cardiac involvement caused by non-IIM reasons (such as stroke);

SSc-related pulmonary hypertension requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active gastric antral vascular ectasia; previous renal crisis caused by SSc;

Trial design

Design model

Single group

Treatments tested in this trial

STR-P004
Biological/Vaccine
STR-P004 Intravenous infusion

Treatment groups

39 Participants

are divided into 3 treatment groups

Group A: DL-1 STR-P004 Amg/kgExperimental treatment 1 intervention

Group B: DL1 STR-P004 Bmg/kgExperimental treatment 1 intervention

Group C: DL2 STR-P004 Cmg/kgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose-limiting toxicity (DLT), all adverse events (AEs)/serious adverse events (SAEs);

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing GoBroad Hospital

Lead sponsor

Starna Therapeutics

Collaborator

Source ClinicalTrials.gov

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