Actively Recruiting
UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
Led by The Second Hospital of Anhui Medical University · Updated on 2026-04-15
15
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy
CONDITIONS
Official Title
UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 years or older, any sex
- Confirmed CD19 or BCMA positivity on B cells by flow cytometry
- Diagnosed with autoimmune hemolytic anemia (including warm antibody type, cold agglutinin disease, mixed type, or other types) based on 2023 Chinese guidelines
- Recurrent or refractory AIHA with symptomatic anemia (hemoglobin <100 g/L) after at least 3 failed treatment lines over 6 months
- Bone marrow function with neutrophil count ≥1.0 x 10^9/L and platelets ≥30 x 10^9/L
- Liver function with ALT ≤3 times upper limit, AST ≤3 times upper limit, total bilirubin ≤2.0 times upper limit (or ≤3.0 times if Gilbert syndrome)
- Renal function with creatinine clearance rate ≥30 ml/min
- ECOG performance status of 2 or less
- Use of medically approved contraception or abstinence during treatment and for 6 months after
- Negative pregnancy test within 7 days before enrollment for females of childbearing potential
- Willingness to participate, sign consent, comply, and cooperate with follow-up
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Presence or suspicion of uncontrolled or treatment-required infections (fungal, bacterial, viral, or others)
- History of recurrent active infections requiring medical intervention within 6 months
- History of CMV, EBV, or fungal infections within 3 months before screening or recurrent infections
- Receipt of any vaccination or participation in vaccine trials within 12 weeks before enrollment
- Insufficient cardiac function
- Moderate to severe congestive heart failure (NYHA Class III-IV)
- Congenital immunoglobulin deficiencies
- History of malignancy in past 5 years except certain low-risk cancers
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infections
- History of organ transplantation
- Severe, progressive, uncontrolled diseases of major organ systems
- Psychiatric disorders or severe cognitive impairment
- Pregnant women or women planning to conceive
- Any other investigator-assessed reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
Research Team
Z
Zhimin Zhai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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