Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
Led by InnoCare Pharma Inc. · Updated on 2025-06-19
78
Participants Needed
8
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 as monotherapy or in combination with anti-CD20 monoclonal antibody in Mature B-cell Malignancies
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with relapsed or refractory CLL/SLL or MCL confirmed by WHO 2016 criteria or iwCLL criteria
- For relapsed/refractory MCL, measurable disease per Lugano 2014 criteria
- Received at least two prior adequate systemic therapies, including at least one with Bruton's kinase inhibitor
- ECOG performance status of 0 or 1 and life expectancy of at least 6 months
- Adequate blood, liver, kidney, lung, and heart function
- Normal coagulation function
- Patients with fertility potential and their partners agree to use contraception
- Ability to communicate well with investigators and complete the study as planned
You will not qualify if you...
- Central nervous system involvement by lymphoma or leukemia
- Known or suspected Richter's transformation
- Prior autologous stem cell transplant less than 3 months ago or prior chimeric cell therapy less than 3 months ago
- History of allogeneic stem cell transplantation
- Use of strong CYP3A or CYP2C8 inhibitors or inducers within five half-lives before starting study drug or planned concurrent use during study
- Active infection requiring intravenous anti-infective therapy
- History of immunodeficiency including positive HIV test
- Significant cardiovascular disease history
- Previous or current central nervous system disorders
- Grade 2 or higher toxicity from prior cancer therapy at screening
- Known alcohol or drug dependence
- Unable to swallow tablets or have significant gastrointestinal diseases affecting absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
BRCR Medical Center
Plantation, Florida, United States, 33322
Actively Recruiting
2
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
3
Pan American Center for Oncology Trials
San Juan, Puerto Rico, 00935
Actively Recruiting
4
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, Ukraine, 18009
Actively Recruiting
5
CNE"City Clin Hosp#4"of Dnipro City Council
Dnipro, Ukraine, 49102
Actively Recruiting
6
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, Ukraine, 1135
Actively Recruiting
7
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, Ukraine, 2091
Actively Recruiting
8
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, Ukraine, 79057
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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