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

Recruiting now · Phase 1

Conditions studied: Mature B-cell Malignancies

In brief

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

Key facts

Study ID

NCT06351527

Run by

InnoCare Pharma Inc.

People needed

78

Starts

2024-04-23

Expected to finish

2027-10-25

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known central nervous system involvement by lymphoma/leukemia.
• Known or suspected history of Richter's transformation.
• Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
• A history of allogeneic stem cell transplantation.
• An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8 inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to the first dose of the investigational product, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong CYP3A or CYP2C8 inhibitory or inductive effect during study participation
• Presence of active infection that currently requires intravenous systemic anti-infective therapy.
• History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
• History of significant cardiovascular disease
• Patients with previous or concomitant central nervous system disorders
• Grade 2 or above toxicity due to prior anti-cancer therapy at screening
• Known alcohol or drug dependence
• Unable to swallow tablets or presence of disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

Where it is running

• BRCR Medical Center — Plantation, Florida, United States (enrolling)
• Clinical Research Alliance — Westbury, New York, United States (enrolling)
• Pan American Center for Oncology Trials — San Juan, Puerto Rico (enrolling)
• CNE CCOHTPC of Cherkasy Regional Council — Cherkasy, Ukraine (enrolling)
• CNE"City Clin Hosp#4"of Dnipro City Council — Dnipro, Ukraine (enrolling)
• Medical Center of Limited Liability Company Arensia Exploratory Medicine — Kyiv, Ukraine (enrolling)
• Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC — Kyiv, Ukraine (enrolling)
• SI Institute of Blood Pathology and Transfusion Medicine of AMSU — Lviv, Ukraine (enrolling)

Full record on ClinicalTrials.gov

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