ICP-248 treatment for relapsed or refractory mantle cell lymphoma

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

This will try ICP-248 in adults whose mantle cell lymphoma has returned or not responded after prior anti-CD20 and BTK inhibitor therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 29 sites (Hefei, Anhui and 28 other locations)
• Trial ID: NCT07082686 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter, open-label phase 2 trial testing ICP-248 in adults with relapsed or refractory mantle cell lymphoma who have failed at least one anti-CD20 regimen and at least one BTK inhibitor. Central pathology confirmation of cyclin D1 expression or t(11;14) is required and patients must have at least one measurable lesion per Lugano 2014 criteria and an ECOG performance status of 0–2. Key exclusions include blastoid or pleomorphic histology, CNS lymphoma, and prior use of BCL-2 inhibitors. The trial will measure tumor responses and safety outcomes to determine whether ICP-248 produces meaningful remissions in this population.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed mantle cell lymphoma (cyclin D1-positive or t(11;14)), relapsed or refractory after at least one anti-CD20 and one BTK inhibitor, with measurable disease and ECOG 0–2 are the intended candidates.

Not a fit: Patients with blastoid or pleomorphic MCL, current or prior CNS lymphoma, prior BCL-2 inhibitor exposure, or those who do not meet the prior-therapy failure requirements are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, ICP-248 could produce remissions or extend disease control for patients whose mantle cell lymphoma has stopped responding to standard anti-CD20 and BTK inhibitor therapies.

How similar studies have performed: Other single-arm phase 2 programs of novel targeted agents in relapsed mantle cell lymphoma have produced responses in some patients, but results have been variable and often depend on prior therapies and disease biology.

Eligibility criteria

Inclusion Criteria:

* ≥ 18 years old.
* Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.
* The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:

  * Failure of at least one adequate prior line of anti-CD20-containing therapy;
  * Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.
* Failure of the last line of therapy.
* At least one measurable lesion according to the Lugano 2014 criteria,.
* ECOG performance status of 0-2 .

Exclusion Criteria

* Blastoid or pleomorphic mantle cell lymphoma (MCL).
* Current or prior history of central nervous system (CNS) lymphoma.
* Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.).
* Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.
* Prior allogeneic hematopoietic stem cell transplantation.

Where this trial is running

Hefei, Anhui and 28 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Chengdu, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xian, Shanxi, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• The Second People's Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)
• The Affiliated Cancer Hospital of Xinjiang Medical University — Xinjiang, Xinjiang, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Alexia Lu

Conditions Relapsed or Refractory Mantle Cell Lymphoma