A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
About this study
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.
- Condition
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- Tested
- ICP-248
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- ≥ 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 4
- 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
29 sites, 29 recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Hospital of Jilin University
Changchun, Jilin, China
Hunan Cancer Hospital
Changsha, Hunan, China
West China Hospital of Sichuan University
Chengdu, Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
and 23 more sites on ClinicalTrials.gov
Contact
-
Alexia Lu
010-66609745 CO_HGRAC@innocarepharma.com
Potential match only. Final eligibility is determined by the study team.