NCT07082686

A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.

Conditions

• Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
DRUG	ICP-248	Eligible patients will receive ICP-248 orally as per the protocol

Timeline

• Start date: 2025-08-21
• Primary completion: 2027-12-01
• Completion: 2028-07-01
• First posted: 2025-07-24
• Last updated: 2025-11-21

Locations

29 sites across 1 country: China