ICP-248 treatment for relapsed or refractory mantle cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

* 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 it's running

• 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

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.