Actively Recruiting
CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-12-13
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
X
Xi'niao Biotech
Collaborating Sponsor
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
CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Positive B cell CD19 or BCMA detected by flow cytometry in peripheral blood
- Diagnosed with autoimmune hemolytic anemia (AIHA), including warm antibody type, cold agglutinin disease, mixed type, or other types, as per 2023 Chinese adult AIHA guidelines
- Recurrent or refractory AIHA after at least three failed lines of treatment with symptomatic anemia (hemoglobin <100 g/L) lasting at least 6 months
- ECOG performance status of 2 or less
- Adequate bone marrow function: neutrophil count ≥ 1.0 × 10^9/L and platelets ≥ 30 × 10^9/L
- Liver function within specified limits: ALT ≤ 3× upper limit, AST ≤ 3× upper limit, total bilirubin ≤ 2.0× upper limit (up to 3.0× for Gilbert syndrome)
- Renal function with creatinine clearance rate ≥ 30 ml/min (Cockcroft/Gault formula)
- Use of medically approved contraception or abstinence during treatment and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not lactating (for women of childbearing potential)
- Willingness to participate, sign informed consent, comply with study visits and follow-up
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Uncontrolled or untreated fungal, bacterial, viral, or other infections
- Central nervous system diseases caused by autoimmune or non-autoimmune conditions
- Insufficient heart function
- Congenital immunoglobulin deficiencies
- History of cancer within the past five years
- End-stage kidney failure
- Positive for hepatitis B surface antigen or core antibody with elevated HBV DNA, hepatitis C antibody with HCV RNA, HIV antibody, or positive syphilis test
- Psychiatric disorders or severe cognitive impairment
- Use of immunosuppressive agents or biologics affecting the disease within five half-lives before enrollment
- Pregnant or planning to become pregnant
- Active infection, active rheumatic or immune disease, or drug-induced or lymphoproliferative tumor-associated secondary AIHA
- Other conditions considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Regenerative Medicine Center and Red Blood Cell Disorders Center
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jun Shi, PhD
CONTACT
L
Lele Zhang, 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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