Study of ICP-248 for Mature B-cell Malignancies
This study is testing a new drug called ICP-248 for people with mature B-cell malignancies (cancers of certain white blood cells). Researchers want to see how safe ICP-248 is, how well your body handles it, and if it helps treat the cancer. ICP-248 will be given by mouth, either alone or with other approved cancer drugs like Obinutuzumab or Rituximab, which are given through an IV. The study is looking for about 78 participants aged 18 or older who have specific types of relapsed or refractory (meaning it came back or didn't respond to previous treatment) B-cell cancers like CLL/SLL or MCL. Success in this study means finding a safe dose of ICP-248 and seeing if it helps patients over a period of up to 5 years. The current recruitment status is unclear.
- Study design
- This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 78 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure safety and tolerability for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
8 sites across 4 statesWho to contact
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What this trial measures
- DLT49 days
Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018.
- Safety and tolerability of ICP-248 at different doses in B-cell malignancies5 years
To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria or iwCLL 2018.