About this trial
This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD20 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
Eligibility criteria
Qualifiers
Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment protocol, laboratory tests, and other study requirements specified in the flow sheet;
B-cell acute lymphoblastic leukemia (B-ALL);
Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
Invasive B-cell lymphoma (DLBCL, BL, and MCL);
Disqualifiers
Appearance of one of the following cardiac criteria: atrial fibrillation; myocardial infarction in the last 12 months; prolonged QT syndrome or secondary QT extension, as judged by the investigator. Echocardiography LVSF <30% or LVEF <50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (confirmed by echocardiography within 12 months of treatment).
Active GVHD.
History of severe pulmonary function impairment disease.
Other malignant tumors in the advanced stage.
Trial design
Treatments tested in this trial
- CD19&CD20 bispecific CAR-T cells
Treatment groups
Sponsors and collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
Zhujiang Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
Shiyan People's Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator