A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- Interventions
- Registration Number
- NCT07082686
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 68
-
≥ 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-248Tablets ICP-248 -
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC) 3 years
- Secondary Outcome Measures
Name Time Method According to Lugano 2014: IRC and investigator assessed complete response rate (CRR) 3 years Investigator-assessed ORR 3 years According to Lugano 2014: IRC and investigator assessed disease control rate (DCR). 3 years According to Lugano 2014: IRC and investigator assessed duration of response (DOR). 3 years According to Lugano 2014: IRC and investigator assessed time to initial response (TTR). 3 years According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) . 3 years Overall survival (OS) 3 years Adverse event (AE) assessed according to CTCAE v5.0 criteria 3 years Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L). 3 years Area under the plasma concentration versus time curve (AUC) 3 years minimal residual disease （MRD） status 3 years Peak Plasma Concentration (Cmax) 3 years Time of maximum observed plasma(Tmax) 3 years Trough concentration(Ctrough) 3 years Apparent clearance (CL/F) 3 years
Trial Locations
- Locations (28)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Scroll for more (18 remaining)The First Affiliated Hospital of Anhui Medical University🇨🇳Hefei, Anhui, ChinaJian GeContact0551-62922800Gejian52@163.com