Status:
NOT_YET_RECRUITING
Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV
Lead Sponsor:
Peking University People's Hospital
Conditions:
Idiopathic Inflammatory Myopathies
ANCA-Associated Vasculitis
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
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 refractor...
Eligibility Criteria
Inclusion
- General
- The subject voluntarily participates in this trial and has signed the informed consent form.
- Age ≥18 years and ≤70 years, regardless of gender.
- Organ Function and Laboratory Tests:
- 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.
- Blood Routine: Neutrophil count ≥1×10\^9/L, hemoglobin ≥60 g/L, platelet count ≥50×10\^9/L, lymphocyte count \>0.3×10\^9/L.
- Coagulation Function: International normalized ratio (INR) ≤1.5×ULN, or prothrombin time (PT) ≤1.5×ULN.
- Oxygen saturation (SpO2) ≥92% at rest while breathing room air.
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test result during screening.
- Females of childbearing potential must agree to use highly effective contraception from at least 28 days before the start of lymphodepletion until 12 months after the infusion of RD06-04. Males of reproductive potential must agree to use an effective barrier method of contraception from the start of lymphodepletion until 12 months after the infusion of RD06-04 and must not donate semen or sperm during the entire trial period.
- For IIM participants:
- 1\. Diagnosed with IIM (including probable or definite diagnosis, i.e., a probability of ≥55%) according to the 2017 ACR/EULAR classification criteria. Currently, the ENMC considers that the subtypes of IIM mainly include dermatomyositis (DM), antisynthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).
- For AAV participants:
- 1\. Meets the diagnostic criteria for ANCA-associated vasculitis as established by the 2022 ACR/EULAR, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).
Exclusion
- 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.
- History of, or current significant cardiovascular dysfunction.
- History of malignancy within 5 years prior to signing the ICF.
- Pregnant or breastfeeding women.
- History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., three or more episodes of the same type of infection within the past year).
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.
- History of drug or alcohol abuse within 1 year prior to screening.
- Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.
Key Trial Info
Start Date :
June 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06986018
Start Date
June 14 2025
End Date
December 31 2026
Last Update
May 22 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100032