ICP-248 alone or with anti‑CD20 antibodies for relapsed or refractory mature B‑cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open‑label trial will give ICP‑248 as monotherapy or together with an anti‑CD20 monoclonal antibody (obinutuzumab or rituximab) to adults with relapsed or refractory CLL/SLL or mantle cell lymphoma. The study will enroll patients who have received at least two prior systemic therapies, including a Bruton's tyrosine kinase inhibitor, and have adequate organ function and ECOG performance status ≤1. Primary activities include dose escalation to define safety, tolerability, and pharmacokinetics, with secondary measures examining preliminary anti‑tumor activity. The trial is sponsored by InnoCare Pharma and is being conducted at several U.S. clinical sites.

Why it matters

Who can join: the full rules

1. Age ≥ 18.
2. Subjects with histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria: relapsed or refractory CLL/SLL, relapsed or refractory MCL. Patients must have received at least two prior lines of adequate systemic therapy before study entry, and at least one prior systemic therapy should include Bruton's kinase inhibitor (BTKi).
3. For subjects with R/R MCL: Patients must have measurable disease per the Lugano 2014 criteria.
4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 1 and a life expectancy of ≥ 6 months.
5. Adequate hematologic, hepatic, renal, pulmonary and cardiac function
6. Patients with basically normal coagulation function
7. Patients with fertility potential and their partners need contraception
8. Subjects can communicate with the investigator well and to complete the study as specified in the study.

Exclusion Criteria:

1. Known central nervous system involvement by lymphoma/leukemia.
2. Known or suspected history of Richter's transformation.
3. Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
4. A history of allogeneic stem cell transplantation.
5. 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
6. Presence of active infection that currently requires intravenous systemic anti-infective therapy.
7. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
8. History of significant cardiovascular disease
9. Patients with previous or concomitant central nervous system disorders
10. Grade 2 or above toxicity due to prior anti-cancer therapy at screening
11. Known alcohol or drug dependence
12. 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's running

• BRCR Medical Center
  Plantation, Florida, United States Recruiting
• Clinical Research Alliance
  Westbury, New York, United States Recruiting
• Pan American Center for Oncology Trials
  San Juan, Puerto Rico Recruiting
• CNE CCOHTPC of Cherkasy Regional Council
  Cherkasy, Ukraine Recruiting
• CNE"City Clin Hosp#4"of Dnipro City Council
  Dnipro, Ukraine Recruiting
• Medical Center of Limited Liability Company Arensia Exploratory Medicine
  Kyiv, Ukraine Recruiting

Study contacts

• Study coordinator: Study Director
• Email: ICP-CL-1202general@innocarepharma.com
• Phone: 609-524-1106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.