A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases. (NCT07203404) | Clinical Trial Compass
RecruitingEarly Phase 1
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
China84 participantsStarted 2025-07-24
Plain-language summary
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent.
✓. Aged ≥18 years and ≤75 years.
✓. Adequate organ function defined as:
✓. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500/μL, absolute lymphocyte count (ALC) ≥100/μL, hemoglobin (Hb) ≥80 g/L, and platelet count (PLT) ≥50,000/μL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.
✓. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \<1.5 × ULN (or \<3.0 × ULN for subjects with Gilbert's syndrome).
✓. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.
✓. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).
✓. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.
Exclusion criteria
✕. Subjects with SLE/LN:
✕. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs/symptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.
What they're measuring
1
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment