Actively Recruiting
A Clinical Study of CD19/BCMA-Targeted Universal Allogeneic CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Hemolytic Anemia Evaluating Safety and Preliminary Efficacy
Led by The Second Hospital of Anhui Medical University · Updated on 2026-04-15
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new universal allogeneic anti-CD19/BCMA CAR T-cell therapy for patients with autoimmune hemolytic anemia (AIHA) who have not responded to three or more previous treatments. This early phase 1 trial focuses on individuals with relapsed or refractory AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other forms, aiming to provide an alternative option for difficult-to-treat cases. The treatment involves a single intravenous infusion of the universal allogeneic CAR T-cells following a lymphodepleting chemotherapy regimen with fludarabine and cyclophosphamide. The study includes an initial treatment period with detailed monitoring and an interim analysis 12 weeks after the infusion to evaluate safety and clinical response. The intervention being tested is a biological therapy called QT-219C Cell Injection. Participants will undergo various assessments including blood tests to measure CAR T-cell levels and monitor organ function, as well as evaluations for adverse events and clinical response up to 24 weeks after treatment. Safety monitoring will continue for up to 12 months post-infusion. The study requires signing informed consent, compliance with contraception requirements for those of childbearing potential, and regular follow-up visits. The total participation duration varies according to individual response and safety monitoring needs.
CONDITIONS
Brief 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
- Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow
- Diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, or other types, following Chinese Adult AIHA Diagnosis and Treatment Guidelines (2023 Edition)
- Refractory or recurrent AIHA after at least 3 failed treatments with symptomatic anemia persisting or recurring after remission
- Adequate bone marrow function with neutrophil count ≥1.0 x 10^9/L and platelets ≥30 x 10^9/L
- Liver function within limits: ALT ≤3 times upper normal limit (ULN), AST ≤3 times ULN, total bilirubin ≤2.0 times ULN (≤3.0 times ULN if Gilbert syndrome)
- Renal function with creatinine clearance rate ≥30 ml/min (using Cockcroft/Gault formula, excluding disease-caused decline)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Use of medically approved contraception or abstinence during treatment and 6 months after; females of childbearing potential must have negative HCG test within 7 days before enrollment and not be lactating
- Willing to participate, sign informed consent, comply with study procedures, and attend follow-up visits
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Presence or suspicion of uncontrolled infections requiring treatment
- History of recurrent infections needing medical care within 6 months before enrollment
- Recent or recurrent cytomegalovirus, Epstein-Barr virus, or fungal infections within 3 months prior to screening
- Vaccination within 12 weeks prior to enrollment or participation in vaccine trials during that time
- Insufficient cardiac function or moderate to severe congestive heart failure (NYHA Class III-IV)
- Congenital immunoglobulin deficiencies
- History of malignancy within the past 5 years except certain low-risk or treated cancers
- Positive tests for hepatitis B (with active viral DNA), hepatitis C, HIV, or syphilis
- History of organ transplantation including bone marrow or stem cell transplantation
- Severe, uncontrolled diseases of major organs or systems
- Psychiatric disorders or severe cognitive impairment
- Pregnant women or those planning to conceive
- Any other investigator-assessed reason making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Several days leading up to infusion
Participants receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to CAR T-cell infusion.
Duration - Single day
Participants receive a single intravenous infusion of universal allogeneic anti-CD19/BCMA CAR T-cells.
1 infusion visit (in-person)
Duration - Up to 24 weeks after infusion
Participants are monitored for safety and clinical response, including adverse events and clinical response assessments.
Regular visits including an interim analysis visit at 12 weeks post-infusion
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
Research Team
Z
Zhimin Zhai, PhD
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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