Publication details
ANNUAL SAFETY REPORT UHKT-CAR19-01 Period: 2. 6. 2024 – 1. 6. 2025
| Authors | |
|---|---|
| Year of publication | 2025 |
| Type | Research report |
| MU Faculty or unit | |
| web | https://ctis.eu/search/trial/2024-510815-30-00.html?from=search |
| Description | The fourth periodic report for study UHKT-CAR19-01 evaluates the safety data received by the study sponsor during the period from June 2, 2024 to June 1, 2025. The clinical study is a monocentric study taking place in the Czech Republic. CD19 positive hematologic malignancies originate from B lymphocytes and comprise a heterogeneous group of neoplasms including B-cell Non-Hodgkin’s lymphomas (B-NHL), as well as B-cell acute lymphoblastic leukemias (B-ALL) and chronic lymphocytic leukemias (CLL). Treatment of B-cell neoplasms is based on combination of chemotherapy, monoclonal antibody therapy and autologous or allogeneic hematopoietic cell transplantation. More recently, therapy with bispecific T cell engagers, immunotoxins and signal pathway inhibitors has been developed for treatment of some of these disorders. Natural course and outcome of treatment of B-cell neoplasms differs significantly among individual diagnostic entities, however, as a general rule, patients who have repeatedly relapsing disease or disease refractory to treatment have poor outcome and novel therapies are urgently needed for these patients. The clinical trial focuses on the effects of CART19 cells in patients with relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin lymphoma. |