Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of… (NCT06986018) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV
China12 participantsStarted 2025-06-14
Plain-language 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 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI)
✕. 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).