A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
Aged 18 to 75 years, regardless of genders.
Diagnosis of AIHA (including warm antibody type, mixed warm and cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with the Chinese Expert Consensus on the Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), or the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults: Recommendations from the First International Consensus Meeting (Blood Rev, 2020), or the Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition).
Hemoglobin < 10 g/dL with clinical manifestations of hemolytic anemia;
After treatment with at least two immunosuppressive agents (which must include an anti-CD20 monoclonal antibody, with a cumulative dose of the anti-CD20 antibody reaching at least 375 mg/m² × 4, or a total dose of 2.0 g, or at least 6 cumulative administrations with an interval of ≥1 week between each);
Previously diagnosed definite lymphoproliferative neoplasms; other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, breast carcinoma in situ, and cervical carcinoma in situ).
Secondary AIHA caused by drugs or infection.
Hepatitis B: HBsAg or HBeAg positive; or hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive with HBV-DNA copy number above the lower limit of detection.
Hepatitis C: Anti-HCV positive and HCV RNA ≥ lower limit of quantification (LLoQ).
Single group
Metabolically Armed Autologous CD19 CAR T-Cell therapy
Biological/VaccineMetabolically Armed Autologous CD19 CAR T-cells. Each subject receive metabolically autologous armed CD19 CAR T-cells by intravenous infusion.
Incidence and severity of adverse events
Assessed by CTCAE Version 6.0.
Proportion of patients achieving response
Response is assessed based on hemoglobin (Hb), laboratory markers of hemolysis (serum bilirubin and lactate dehydrogenase), and transfusion requirements.
The maximum concentration (Cmax)
The Cmax of CAR-T cell expansion in peripheral blood.
Time to Peak (Tmax)
The time to reach the maximum concentration (Tmax).
AUC(0-day 28)
AUC(0- day28) refers to the area under curve of CAR T-cell expansion between infusion and day 28 post infusion.
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Hangzhou Leman Biotech Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
