Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 30, 38, 70, and 123 Targeting B Cell Malignancies

What this Trial Is About

Researchers are studying a new combination of gene-modified T cells called 4th generation chimeric antigen receptor (CAR) T cells targeting several markers (CD19, CD20, CD22, CD30, CD38, CD70, CD123) on B cell cancers. This phase I/II trial aims to assess the safety and effectiveness of these CAR-T cells in patients with B cell malignancies who have relapsed or not responded to standard treatments. The study also focuses on developing a standardized method to produce these CAR-T cells using lentiviral vectors. Participants will undergo a preparation phase where their T cells are collected from blood and genetically modified with the 4SCAR lentiviral vectors targeting the multiple CD markers. Before receiving the CAR-T cell infusion, patients will have a conditioning regimen with chemotherapy drugs cyclophosphamide and fludarabine to prepare their immune system. After infusion of the modified T cells, participants will be closely monitored for treatment responses and potential side effects. Throughout the study, patients will be regularly checked for clinical responses and the presence of CAR-T cells in their blood. The main measure is safety, evaluating adverse events over 24 weeks, while anti-tumor activity will be followed for one year. Participants will be monitored according to a preset schedule, and the entire process includes screening, cell preparation, treatment, and long-term follow-up to assess outcomes and safety.

Combination CAR-T Cell Therapy Targeting Hematological Malignancies