Actively Recruiting
Anti CD19/BCMA CAR Gene Therapy for Relapsed/Refractory Immune Thrombocytopenia
Led by Anhui Provincial Hospital · Updated on 2025-08-08
18
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed and refractory immune thrombocytopenia. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19/BCMA CAR gene vector injection
CONDITIONS
Official Title
Anti CD19/BCMA CAR Gene Therapy for Relapsed/Refractory Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Clinical diagnosis of primary immune thrombocytopenia for at least 6 months
- Platelet count less than 30 x 10^9/L within 48 hours before participation
- Positive anti-platelet glycoprotein autoantibodies (e.g., GPIIb/IIIa)
- Prior ineffective second-line ITP therapy or relapse after treatment
- Bone marrow exam showing megakaryocytosis or normal findings
- Normal vital organ functions: ejection fraction 6%, normal ECG, creatinine clearance 30 mL/min, liver enzymes within limits, adequate blood counts, oxygen saturation above 92%, ECOG performance status 0-2
- Agreement to use contraception if of childbearing potential and negative pregnancy test before treatment
You will not qualify if you...
- Thrombocytopenia caused by other diseases like myelodysplastic syndrome or thrombotic thrombocytopenic purpura
- Bone marrow fibrosis grade 2 or higher or other bone marrow diseases causing thrombocytopenia
- History of severe allergic reaction to study medication components
- Severe heart conditions including recent heart attack or heart failure class III-IV
- Cancer within 3 years unless fully treated and inactive
- Recent deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Participation in other interventional clinical trials within 1 month
- Recent live vaccine within 4 weeks
- Recent stroke or seizure within 6 months
- Positive tests for active hepatitis B, hepatitis C, HIV, or syphilis infections
- Known bone marrow stem cell diseases
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Siweikang Therapeutic Co.Ltd
Changsha, Hunan, China, 410119
Actively Recruiting
Research Team
B
bing xing wang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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