NX-5948-301 A Phase I study to determine the best dose(s) for the treatment of adult patients with B-cell lymphoma or leukemia who have relapsed and/or have not responded to other treatment with the investigational compound NX-5948, which degrades the enzyme Bruton's tyrosine kinase.
Summary of the study
The aim of this study is to find out what effect the study drug NX-5948 has on patients suffering from B-cell lymphoma or B-cell leukemia. This study is an international study. It is being conducted at several study centers in countries in the European Union, Switzerland, the United Kingdom and the USA. A total of 572 people are expected to take part in the study. The study consists of three parts: 1. in the first part, the dose of the test substance will be gradually increased (dose escalation). (The enrollment of participants in this part of the study has been completed). 2. in the second part, the safety and efficacy of selected optimal doses are investigated (safety dose escalation). 3. the third part will investigate the safety and efficacy of selected doses in people with CLL/SLL (cohort extension). In this study, patients suffering from B-cell lymphoma or B-cell leukemia are included. This study will investigate whether different doses of the investigational drug NX-5948 are safe and well tolerated and whether NX-5948 is effective in B-cell lymphoma. Participation in this study will take place in four consecutive steps: 1. screening: patients will undergo various tests to determine whether they are suitable for participation in the study. 2. treatment: patients take the test substance NX-5948 at regular intervals and are regularly examined. 3. safety observation: After taking the last dose of NX-5948, patients will be followed up three times within 30 days. 4. long-term follow-up for a maximum of five years.
(BASEC)