It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.
Name: ICP-022
Description: The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
Measure: Overall response rate(ORR) Time: Up to 3 yearsDescription: The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
Measure: Occurrence of adverse events and serious adverse events Time: Up to 3 yearsDescription: The efficacy measured by progression free survival(PFS)
Measure: Progression free survival(PFS) Time: Up to 3 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Key Inclusion criteria: 1. Men and women between 18 and 75 years old, 2. Histologically confirmed diffuse large B-cell lymphoma(DLBCL)with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI, 3. ECOG performance status of 0-2, 4. Voluntary written informed consent prior to trail screening. --- L265P ---