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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. Any positive results of contagious diseases as following:
. Active tuberculosis or latent tuberculosis that has not been adequately treated
. Evidenced viral, bacterial or fungal infection that is uncontrolled or requires systemic antimicrobial therapy