Actively Recruiting
The Study of ICP-248 in Patients With Mature B-cell Malignancies
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2025-09-08
191
Participants Needed
22
Research Sites
190 weeks
Total Duration
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AI-Summary
What this Trial Is About
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.
CONDITIONS
Official Title
The Study of ICP-248 in Patients With Mature B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis of CLL/SLL, MCL, or specific B-cell non-Hodgkin lymphomas confirmed by pathology or flow cytometry
- Disease that has returned or not responded to prior treatment
- Measurable disease for B-NHL patients
- ECOG performance status of 2 or less and life expectancy of at least 6 months
- Adequate blood counts and normal blood clotting function
- Adequate liver, kidney, lung, and heart function
- Specific lymph node size or lymphocyte count criteria for enrollment
- Negative pregnancy test for females of childbearing potential and agreement to use birth control
- Ability to communicate well with study staff and complete study requirements
- Understanding of the study and voluntary signing of informed consent
- CLL/SLL patients must have a treatment indication as judged by the investigator
You will not qualify if you...
- Other cancers diagnosed within 2 years before study entry
- Cancer involvement in the central nervous system
- Medical conditions that could make study treatment unsafe or affect results
- Recent stem cell transplant or chimeric cell therapy unless at least 3 months ago
- Previous use of BCL-2 inhibitors without achieving remission unless disease recurred after stopping
- History of allogeneic stem cell transplantation
- Anti-cancer therapy within 14 days before starting study treatment
- Recent use or planned use of drugs or supplements strongly affecting CYP3A enzyme
- Major surgery or significant injury within 28 days before treatment or planned surgery during study
- Live vaccines within 28 days before treatment (except for major public health events)
- Active infections requiring intravenous antibiotics
- Active hepatitis B or C infection
- History of immunodeficiency including HIV
- Significant heart disease history
- Current or past severe lung disease or central nervous system disorders
- Significant side effects from previous cancer treatments (except specific blood count issues)
- Severe bleeding disorders
- Known alcohol or drug dependence
- Mental health disorders or poor compliance
- Pregnant or breastfeeding females
- Inability to swallow tablets or severe gastrointestinal problems
- Allergy to ICP-248, Orelabrutinib, or related products
- Certain aggressive forms of mantle cell lymphoma requiring special review before inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233099
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
5
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
6
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
7
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510062
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
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9
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450008
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10
The Central Hospital of Wuhan
Wuhan, Hubei, China, 430014
Actively Recruiting
11
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
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12
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
13
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
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14
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
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15
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
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16
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116027
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17
Shenyang Hospital Of China Medical University
Shenyang, Liaoning, China, 110022
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18
Shandong cancer hospital
Jinan, Shandong, China, 250117
Actively Recruiting
19
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
20
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
21
Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
22
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Shuhua Yi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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