ANNUAL SAFETY REPORT UHKT-CAR19-01 Period: 2. 6. 2024 – 1. 6. 2025
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F25%3A00143492" target="_blank" >RIV/00216224:14110/25:00143492 - isvavai.cz</a>
Výsledek na webu
<a href="https://ctis.eu/search/trial/2024-510815-30-00.html?from=search" target="_blank" >https://ctis.eu/search/trial/2024-510815-30-00.html?from=search</a>
DOI - Digital Object Identifier
—
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
ANNUAL SAFETY REPORT UHKT-CAR19-01 Period: 2. 6. 2024 – 1. 6. 2025
Popis výsledku v původním jazyce
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.
Název v anglickém jazyce
ANNUAL SAFETY REPORT UHKT-CAR19-01 Period: 2. 6. 2024 – 1. 6. 2025
Popis výsledku anglicky
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.
Klasifikace
Druh
V<sub>souhrn</sub> - Souhrnná výzkumná zpráva
CEP obor
—
OECD FORD obor
30230 - Other clinical medicine subjects
Návaznosti výsledku
Projekt
—
Návaznosti
—
Ostatní
Rok uplatnění
2025
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Počet stran výsledku
46
Místo vydání
Praha
Název nakladatele resp. objednatele
ÚHKT
Verze
—