CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • QT-019C

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators