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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • QT-019C

    Biological/Vaccine

    universal allogeneic anti-CD19/BCMA CAR T-cells

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: QT-019CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 28 Days After QT-019C infusion
2

The total number, incidence, and severity of AEs

2\. The total number, incidence, and severity of AEs

Time frame
Up to 12 Months After QT-019C Infusion

Secondary outcomes

1

Clinical response of R/R AIDs

Clinical response of R/R AIDs

Time frame
Up to 24 Months After UCAR T-cell Infusion

Other outcomes

Sponsors and contacts

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