Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies (NCT05513612) | Clinical Trial Compass
WithdrawnPhase 1
Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies
Stopped: The study is not initiated and we want it to be withdrawn.
China0Started 2020-08-01
Plain-language summary
The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.
Exclusion criteria
✕. Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).
✕. 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).
✕. History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.
✕. 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.