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A Study to Evaluate the Effic...

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

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-248Tablets

Group Type EXPERIMENTAL

ICP-248

Intervention Type DRUG

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

Interventions

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ICP-248

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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