An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Cell Therapy Group Co.,Ltd

About this trial

This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in patients with relapsed or refractory active autoimmune diseases, including idiopathic inflammatory myopathies(IIM), immune thrombocytopenia(ITP), systemic lupus erythematosus(SLE).

Eligibility criteria

Qualifiers

Males or females, aged 18-70 years old

Bone marrow reservation: absolute neutrophil count (ANC) ≥1 ×10^9/L; absolute lymphocyte count (ALC)≥ 0.5 ×10^9/L; hemoglobulin ≥80 g/L; platelets ≥50 ×10^9/L(except for ITP);

Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 upper limit of normal(ULN) (except for elevations are evaluated to be related to autoimmune disease by investigators)and ii: total bilirubin ≤ 2 ULN, (except for Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).

Renal function: serum creatinine ≤ 1.5 ULN , or estimated glomerular filtration rate(eGFR) ≥ 60 mL/min/1.73m2 [eGFR=186×age^-0.203×SCr^-1.154(mg/dl),female×0.742]

Disqualifiers

A history of severe hypersensitivity or allergic reactions, or contraindications or hypersensitivity to any component of the investigational drug

Presence of any serious heart diseases defined in the protocol

A medical history of severe central nervous system or symptoms within 6 months

Any concurrent malignancy or a history of malignancy with exceptions indicated in the protocol

Trial design

Treatments tested in this trial

  • CD19/CD22/BCMA CAR-T cells(BZE2204)

Treatment groups

20 Participants
are divided into 1 treatment group