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

InnoCare Pharma

Status and phase

Enrolling

Phase 2

Conditions

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Treatments

Drug: ICP-248

Study type

Interventional

Funder types

Industry

Identifiers

NCT07082686

ICP-CL-01206

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.