Recruiting
Phase 1

ICP-248 & Anti-CD20

Sponsor:

InnoCare Pharma Inc.

Code:

NCT06351527

Conditions

Mature B-cell Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ICP-248

Obinutuzumab (G)

Rituximab (R)

Study Details

Brief 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

Conditions

Mature B-cell Malignancies

Study ID

NCT06351527

Start date

Apr 23, 2024

Status verified date

Jun, 2025

Completion date

Oct 25, 2027

Anticipated

Primary completion date

Jun 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose-Escalation Cohort - CLL/SLL and MCL

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.

experimental: Dose-Expansion Cohort A - CLL/SLL

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and obinutuzumab for 6 cycles. Cycles will comprise 28 days.

experimental: Dose-Expansion Cohort B - MCL

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.

experimental: Dose-Expansion Cohort C - MCL

Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and Rituximab for 18 cycles. Cycles will comprise 28 days.

Interventions

ICP-248

ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).

Obinutuzumab (G)

Obinutuzumab will be administered by IV infusion at a dose of 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6.

Rituximab (R)

Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m\^2) at Day 1 per week for 4 weeks during cycle 1, then on day 1 of cycles 3-8, and thereafter once every other cycle up to 2 years.

Primary outcome measure

  • DLT [ Time Frame: 49 days ]
  • Safety and tolerability of ICP-248 at different doses in B-cell malignancies [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

BRCR Medical Center

Recruiting

Plantation, Florida, United States, 33322

Clinical Research Alliance

Recruiting

Westbury, New York, United States, 11590

More Information

Sponsor

InnoCare Pharma Inc.

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InnoCare Pharma Inc. on 2025-06-19.