This is an open-label, investigator-initiated clinical trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with refractory IIM and AAV. The study plans to enroll a total of 12 participants, with 6 cases each for IIM and AAV. Enrollment for both diseases will proceed in parallel. The dose will be 6×10\^6 CAR+T cells/kg (±30%), and patients will receive a single infusion of RD06-04.
The subject voluntarily participates in this trial and has signed the informed consent form.
Age ≥18 years and ≤70 years, regardless of gender.
Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except for Gilbert syndrome).
Renal Function: Creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
As determined by the investigator, the primary diagnosis is a rheumatic autoimmune disease other than the disease under study, which the investigator believes may confound the efficacy evaluation of the study disease.
Clinically significant central nervous system disease or pathological changes not caused by the non-study disease within 12 months prior to screening.
History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart, liver) or plans for such transplantation in the future.
For IIM patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
Single group
RD06-04 Cell Injection Infusion
DrugCAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)
The proportion of patients with kidney involvement achieving complete kidney remission (CRR)
The change in UPCR from baseline in patients with kidney involvement.
The change in eGFR (estimated glomerular filtration rate) from baseline in patients with kidney involvement.
The change in BVAS score from baseline in AAV patients
Birmingham Vasculitis Activity Score (BVAS) has a minimum score of 0 and a theoretical maximum score exceeding 100 (depending on the number and severity of affected organ systems). A higher score indicates stronger disease activity and a worse prognosis, while a decrease in score (especially to \<5) typically suggests effective treatment.
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This trial is not recruiting at the moment. You can still explore other options:
