New drug STR-P004 aims to tame immune attacks on kidneys

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 4.Adequate organ function: 1. 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. 2. 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). 3. Coagulation function: defined as International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN. 4. Pulmonary function: defined as ≤ CTCAE Grade 1 dyspnea and oxygen saturation (SpO2) ≥92% on room air at rest (by pulse oximetry). 5\. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective contraceptive methods from signing ICF until 1 year after STR-P004 infusion (including during study treatment interruption). Male subjects with partners of childbearing potential must agree to use effective barrier contraception methods for 1 year after STR-P004 infusion and should not donate semen or sperm during the entire study period. 6\. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and within 48 hours prior to STR-P004 infusion. Women who have undergone sterilization or are postmenopausal for at least 2 years are considered not of childbearing potential. Exclusion Criteria: * 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. 2\. Rapidly progressive glomerulonephritis not related to SLE/LN, AAV/AAGN, Anti-GBM Disease, MN, APSN, and IgG4-RKD, defined as ≥50% reduction in eGFR within 3 months since diagnosis. 3\. Other uncontrolled serious conditions not directly related to the disease prior to screening, such as severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.