About this trial
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old (inclusive), regardless of gender.
Functional requirements for major organs are as follows(Except for abnormalities related to autoimmune disease activity): 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30mL/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is excluded).
Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative human chorionic gonadotropin (hCG) test within 7 days before study enrollment and not be lactating.
Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Disqualifiers
Subjects with a history of severe drug allergies or allergic tendencies.
Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).
Subjects with insufficient cardiac function.
Trial design
Single group
Treatments tested in this trial
QT-019C
Biological/Vaccineuniversal allogeneic anti-CD19/BCMA CAR T-cells
Treatment groups
Trial outcomes
Primary outcomes
The number and severity of dose-limiting toxicity (DLT) events
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
The total number, incidence, and severity of AEs
2\. The total number, incidence, and severity of AEs
Secondary outcomes
Clinical response of R/R AIDs
Clinical response of R/R AIDs
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Shanghai Xiniao Biotech Co., Ltd.
Collaborator