Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing Bioheng Biotech Co., Ltd.
About this trial
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subjects voluntarily participated in the study and signed the informed consent form.
Age ≥18 years old and ≤70 years old, both sexes.
Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).
Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
Disqualifiers
SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.
IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
Trial design
Design model
Single group
Treatments tested in this trial
RD06-05 CART Cell Injection
DrugCAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: RD06-05Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment
Time frame
2 YearsSponsors and contacts
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Source ClinicalTrials.gov