CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

80 Participants
are divided into 1 treatment group

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