Actively Recruiting
Phase 2 Study of ICP-248 Tablets to Treat Adults with Relapsed or Refractory Mantle Cell Lymphoma
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-07-23
75
Participants Needed
29
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of the drug ICP-248 in adults with relapsed or refractory mantle cell lymphoma MCL, a type of cancer affecting the lymphatic system. This is an open-label, single-group, phase 2 study conducted at multiple centers. Participants must have failed previous treatments including anti-CD20 therapy and BTK inhibitors, and have measurable disease according to recognized criteria. Participants will receive ICP-248 orally following the study protocol. There is no comparator group as this is a single-arm study. The treatment period and follow-up extend up to three years, during which researchers will monitor response rates, disease control, survival, drug levels in the blood, and quality of life measures. These assessments will be conducted according to established lymphoma evaluation standards. Throughout the study, participants will undergo regular evaluations including imaging to measure tumor response, blood tests to assess drug levels and minimal residual disease, and questionnaires to evaluate quality of life. Safety will be monitored by tracking adverse events. The main outcome is the overall response rate assessed by an independent committee over three years. Participants health status and treatment effects will be closely observed during this extended period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
Research Team
A
Alexia Lu
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
