RecruitingPhase 2NCT07082686

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

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

75 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ICP-248 in people with mantle cell lymphoma (a type of blood cancer affecting immune B-cells) that has come back or stopped responding to treatment, including prior therapy with a class of drugs called BTK inhibitors. The goal is to see how safe and effective ICP-248 is in this challenging situation. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma - Your lymphoma has relapsed or not responded to at least one prior anti-CD20 treatment and at least one prior BTK inhibitor treatment - You have at least one measurable area of disease on imaging - Your overall health is acceptable (ECOG 0–2) **You may NOT be eligible if...** - Your lymphoma is a particularly aggressive subtype (blastoid or pleomorphic MCL) - Your lymphoma has spread to the brain or spinal cord - You have previously received a BCL-2 inhibitor (such as venetoclax) - You have had a stem cell transplant or CAR-T cell therapy very recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGICP-248

Eligible patients will receive ICP-248 orally as per the protocol

Locations(29)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

West China Hospital of Sichuan University

Chengdu, Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07082686

Related Trials

Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma

NCT074603621 location