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

Last updated: June 17, 2025
Sponsor: InnoCare Pharma Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ICP-248

Rituximab (R)

Obinutuzumab (G)

Clinical Study ID

NCT06351527
ICP-CL-01202
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

  1. Age ≥ 18.

  2. Subjects with histopathologically and/or flow cytometry-confirmed diseases accordingto the 2016 World Health Organization (WHO) classification criteria forlymphohematopoietic neoplasms or meeting the International Workshop on ChronicLymphocytic Leukemia (iwCLL) criteria: relapsed or refractory CLL/SLL, relapsed orrefractory MCL. Patients must have received at least two prior lines of adequatesystemic therapy before study entry, and at least one prior systemic therapy shouldinclude Bruton's kinase inhibitor (BTKi).

  3. For subjects with R/R MCL: Patients must have measurable disease per the Lugano 2014criteria.

  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 asspecified in the study.

Exclusion

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 priorchimeric 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 CYP2C8inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to thefirst dose of the investigational product, or a plan to use concurrentlymedications, dietary supplements or food (e.g., grapefruit or grapefruit juice) withstrong CYP3A or CYP2C8 inhibitory or inductive effect during study participation

  6. Presence of active infection that currently requires intravenous systemicanti-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 affectinggastrointestinal function such as malabsorption syndrome, resection of the stomachor small bowel, bariatric surgery procedures, symptomatic inflammatory boweldisease, or partial or complete bowel obstruction.

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: ICP-248
Phase: 1
Study Start date:
April 23, 2024
Estimated Completion Date:
October 25, 2027

Connect with a study center

  • Pan American Center for Oncology Trials

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • CNE CCOHTPC of Cherkasy Regional Council

    Cherkasy, 18009
    Ukraine

    Active - Recruiting

  • CNE"City Clin Hosp#4"of Dnipro City Council

    Dnipro, 49102
    Ukraine

    Active - Recruiting

  • Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

    Kyiv, 2091
    Ukraine

    Active - Recruiting

  • Medical Center of Limited Liability Company Arensia Exploratory Medicine

    Kyiv, 1135
    Ukraine

    Active - Recruiting

  • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

    Lviv, 79057
    Ukraine

    Active - Recruiting

  • BRCR Medical Center

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.