This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
1. Willing and able to provide written informed consent. 2. Age between 18 and 75 years (inclusive). 3. Confirmed CD19-positive B cell expression in peripheral blood by flow cytometry.
Bone marrow function: defined as absolute neutrophil count (ANC) ≥1500 /μL, absolute lymphocyte count (ALC) ≥100 /μL, hemoglobin (Hb) ≥80 g/L, platelet count (PLT) ≥50,000 /μL. Use of transfusions or growth factors to meet these requirements within 7 days prior to screening is not allowed.
Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN, total bilirubin <1.5×ULN (<3.0×ULN for subjects with Gilbert's syndrome).
Coagulation function: defined as International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.
1. Any clinically significant underlying disease, other than SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, that, in the investigator's opinion, poses a safety risk or problem.
Single group
STR-P004 dose group
DrugThree dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg.
Incidence of DLT, SAE, and Treatment-Emergent Adverse Events (TEAE).
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Starna Therapeutics
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
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