The goal of this clinical trial is to learn if HY001N cell injection safety and tolerability in adult patients with autoimmune hemolytic anemia after failure of 3 or more lines of therapy. It will also learn about the efficacy of HY001N cell injection to treat adult patients with autoimmune hemolytic anemia. The main questions it aims to answer are:
Proportion of participants attaining a CR (defined as normalization of hemoglobin not attributed to transfusion effect and the normalization of hemolytic markers) or CRi (defined as normalization of hemoglobin not attributed to transfusion effect without normalization of hemolytic markers) after HY001N infusion? Proportion of participants attaining a PR (defined as hemoglobin ≥ 100 g/L or at least ≥ 20 g/L increase from baseline not attributed to transfusion effect) after HY001N infusion.
• What medical problems do participants have when taking HY001N cell injection?
Researchers will see if HY001N cell injection works to treat autoimmune hemolytic anemia.
Participants will:
* Take apheresis, lymphodepletion regimen and HY001N cell injection. * Visit the clinic on schedule.
Participant and/or participant's legal representative fully understand and voluntarily sign informed consent forms;
Aged 18 to 75 years, regardless of gender;
Participants with autoimmune hemolytic anemia or Evans syndrome after Failure ≥3 lines of therapy. The Failure of ≥3 lines of therapy meet all the following conditions: Hemoglobin less than 10g/dL and symptoms of anemia;
Women of childbearing age must have a negative blood pregnancy test within 7 days prior to the initiation of conditioning. Any male or female subject of reproductive potential must agree to use effective contraception throughout the study period and for at least 2 year following the infusion of CAR T-cells. In the judgment of the investigator, a subject of reproductive potential refers to having the biological capacity to conceive or father a living child and being sexually active. Women who considered infertile (i.e., meeting at least one of the following criteria): Has undergone a hysterectomy or bilateral oophorectomy, or Medically confirmed ovarian failure, or is medically confirmed as postmenopausal (defined as at least 12 consecutive months of amenorrhea without pathological or physiological causes).
History of lymphoproliferative neoplasms
Secondary AIHA caused by drugs or infection
Pregnancy or lactation
Previously received organ or hematopoietic stem cell transplantation
Single group
HY001N Cell Injection
DrugDrug: HY001N Cell Injection The 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\^5 CAR-T live cells /kg body weight Group A (initial dose) : 0.5×10\^5 CAR-T live cells /kg body weight Group B: 1.0×10\^5 CAR-T live cells /kg body weight Group C: 1.5×10\^5 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 (CTCA, Version 6.0)
The safe dosage for a single infusion of HY001N Cell 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 HY001N Cell 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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