Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

Korábbi kezelés

• History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.
• Prior CAR-T therapy or other genetically modified T cell therapy.

Más betegség

• History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions).
• Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
• Uncontrolled fungal, bacterial, viral, or other infection.
• Acute or chronic graft-versus-host disease (GVHD).
• History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease.
• History or clinical evidence of CNS disease.

Egyéb

• Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).
• Female subjects who are pregnant or lactating.

• Ability to understand and the willingness to sign informed consent.
• Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
• Adequate organ functions:
  • Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen;
  • Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) > 30 mL/min/1.73 m\^2;
  • Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) <2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL;
  • Left ventricular ejection fraction (LVEF) > 40%.
• Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.