Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia

Lab values

• Patients who fulfil any of the following criteria may not be enrolled.
  • Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \>30%;
  • Intracranial hypertension or cerebral impaired consciousness;
  • Symptomatic heart failure or severe arrhythmia;
  • Symptoms of severe respiratory failure;
  • With other types of malignancy;
  • Diffuse intravascular coagulation;
  • Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
  • With sepsis or other uncontrollable infection;
  • Suffering from uncontrollable diabetes mellitus;
  • Severe mental disorders;
  • Have significant intracranial lesions on cranial MRI;
  • Organ transplantation (excluding haematopoietic stem cell transplantation) history;
  • Female patients (patients of childbearing potential) with positive blood HCG test;
  • Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.

• Patients who met all the inclusion criteria were eligible for enrolment.
  • Patients diagnosed with primary resistance acute myeloid leukemia, tumour surface antigen CD33 expression, chemotherapy relapse, extramedullary relapse, persistent residual positivity or relapse/refractory after allogeneic haematopoietic stem cell transplantation;
  • Age 1-70 years old;
  • No severe allergies;
  • Physical condition: 0-2 ECOG score;
  • Expected survival ≥ 60 days;
  • Bone marrow or cerebrospinal fluid tumour cells are positive for CD33 by flow cytometry assay or tumour tissues positive for CD33 by immunohistochemistry (CD33 determination of positivity: flow cytometry: \>80% of tumour cells expressing CD33 and MFI similar to normal myeloid cells is considered as full positivity; tumour cells greater than 80% of expression of CD33 but MFI lower than the CD33 expression of normal myeloid cells by 1 log is considered as low expression (dim). Tumour cells with between 20-80% positive CD33 expression are partially expressed; Pathological immunohistochemistry: tumour cells\>30% positive are considered to be positively expressed;
  • Self-aware patients aged 19-70 years are required to voluntarily sign an informed consent form in writing; paediatric patients aged 1-7 years can be recruited after their legal representative (guardian) had signed an informed consent form; self-aware paediatric patients aged 8-18 years voluntarily sign an informed consent form in writing, and their legal representative (guardian) are required to sign an informed consent form in writing as well;
  • Suitable and available allogeneic haematopoietic stem cell transplant donors are required, and allogeneic haematopoietic stem cell transplantation can be performed after receiving FL-33 CAR T treatment.