Relapsed/Refractory Autoimmune Diseases
Conditions
Keywords
SLE, dcSSc, ANCA, AAV, IIM, SS
Brief summary
This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed/refractory autoimmune diseases. The study will employ a traditional "3+3" dose-escalation design, with 3 dose groups: XXmg/kg, XXmg/kg, XXmg/kg. Dose Group 1 is the starting dose. This group includes two cohorts, A and B, to optimize the dosing frequency of STR-P005. Cohort A will receive doses Q3D (once every 3 days) on Days 1, 4, 7 (3 doses per cycle), for up to 2 cycles. Cohort B will receive doses Q4D (once every 4 days) on Days 1, 4 (2 doses per cycle), for up to 2 cycles. Based on preliminary safety, efficacy, PK/PD data from Cohorts 1A and 1B, the superior regimen will be selected for escalation to Dose Groups 2 and 3. If no optimal dose is identified after escalating through the 3 dose groups, additional higher doses may be explored after SRC discussion based on all accumulated preliminary safety, efficacy, and PK/PD data to further evaluate the safety and efficacy of STR-P005.
Interventions
DRUGSTR-P005 dose group
STR-P005 infusion
Sponsors
Beijing GoBroad Hospital
Starna Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Voluntarily participate and sign informed consent. 2. Age 18 to 75 years (inclusive). 3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry. 4\. Adequate organ function: 1. Hematology: Absolute neutrophil count (ANC) ≥1.0×10\^9\^/L, absolute lymphocyte count (ALC) ≥0.1×10\^9\^/L, hemoglobin ≥80 g/L, platelet count (PLT) ≥50×10\^9\^/L. Transfusion and growth factors cannot be used within 7 days prior to screening to meet these requirements. 2. Coagulation: International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN. 3. Liver function: Serum AST, ALT ≤3.0 × ULN, total bilirubin ≤1.5 × ULN (for participants with Gilbert's syndrome, total bilirubin \<3.0 × ULN). 4. Renal function: Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft Gault formula); if renal involvement, CrCl ≥45 mL/min. \| 5. Cardiac function: New York Heart Association (NYHA) class I or II, left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or ischemic heart disease (IHD) within 8 weeks prior to screening. 6. Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.
Exclusion criteria
* Participants meeting \*\*ANY\*\* of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
Outcome results
None listed