An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refract… (NCT07174843) | Clinical Trial Compass
RecruitingEarly Phase 1
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
China20 participantsStarted 2025-09
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or females, aged 18-70 years old
✓. Adequate bone marrow, hepatic, renal, coagulation and pulmonary function defined as:
✓. Life expectancy \> 6 months
✓. Subjects with relapsed or refractory active IIM also need meet following criteria:
✓. Physician global activity assessment (PGA) ≥ 2 cm (Visual analogue scale VAS 10 cm);
✓. Patient global activity assessment (PtGA) ≥ 2 cm ( VAS 10 cm scale);
✓. Extramuscular global assessment (Myositis Disease Activity Assessment Tool \[MDAAT\]) ≥ 2.0 cm (VAS 10 cm scale);
✓. Health assessment questionnaire (HAQ) \> 0.25;
Exclusion criteria
✕. 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
✕. Clinically significant hemorrhage symptoms or definite bleeding tendencies (except for events caused by ITP) within 6 months prior to screening; arteriovenous thrombosis events within 6 months prior to screening
What they're measuring
1
The frequency and severity of adverse events(AE) and serious adverse events(SAE)
Timeframe: From leukapheresis to 6 months post CAR-T infusion