This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of treatment.
Age range: 18-75 years (including 18 and 75 years), regardless of gender.
The Eastern Cancer Consortium (ECOG) performance status score is 0-2.
Previously diagnosed proliferative tumors of the lymphatic system;
Secondary AIHA caused by drugs or infections;
Pregnancy or breastfeeding;
Previously undergone organ or hematopoietic stem cell transplantation;
Single group
Inaticabtagene Autoleucel Injection
DrugThe dose was incremented according to the "3+3" principle, and the three dose levels A, B and C were given in sequence at one time, which were respectively: A-1 dose group: 0.25×10\^6 CAR-T live cells /kg body weight Group A (initial dose) : 0.5×10\^6 CAR-T live cells /kg body weight Group B: 1.0×10\^6 CAR-T live cells /kg body weight Group C: 1.5×10\^6 CAR-T live cells /kg body weight
Incidence of Treatment-related Adverse Events
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The safe dosage for a single infusion of Inaticabtagene Autoleucel Injection
The safe dosage for AIHA patients will be evaluated by comprehensively assessing the Overall Response Rate (ORR) and the incidence of adverse events (AEs).
Overall Remission Rate (ORR)
The proportion of subjects achieving CR, CRi or PR after treatment by Inaticabtagene Autoleucel Injection. CR is defined as clinical symptoms disappear, Hb≥110g/L (female) or Hb≥120g/L (male); the levels of hemolysis-related laboratory indicators (serum bilirubin and lactate dehydrogenase) return to normal. For CAD patients, CR criteria also include: undetectable clonal B cells and clonal IgM. Hematological complete remission with compensatory hemolytic state (CRi) is defined as Hb≥110g/L (female) or Hb≥120g/L (male); and hemolysis-related laboratory indicators (serum bilirubin and lactate dehydrogenase) improve but do not return to normal levels. Partial response (PR) is defined as Hb ≥ 100 g/L or an increase of ≥ 20 g/L from baseline; and at least 7 days without blood transfusion.
Changes in laboratory test indicators
Changes in Hemoglobin,reticulocytes, serum bilirubin, lactate dehydrogenase, and haptoglobin; clonal B cells and monoclonal immunoglobulin.
Drug-free Remission (DFR)
The duration from achieving CR, CRi, or PR to the time of relapse
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