Health Trials

The Study of ICP-248 in Patients With Mature B-cell Malignancies

ConditionHematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.

Eligibility criteria

Qualifiers

Age ≥ 18 and ≤ 80 years.

One of the following 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: Histopathologically and/or flow cytometry-confirmed CLL/SLL; Pathologically confirmed MCL; Pathologically confirmed B-NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and lymphoplasmacytic lymphoma (LPL).

Relapsed disease or refractory disease

For subjects with B-NHL: Patients must have measurable diseasePatients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.

Disqualifiers

Prior malignancy (other than the disease under study) within 2 years before study entryKnown

Central nervous system involvement by lymphoma/leukemia

Underlying medical conditions that, in the investigator's opinion, will render the administration of the investigational product hazardous or obscure the interpretation of the safety or efficacy results.

Prior autologous stem cell transplant (unless ≥ 3 months after transplant); or prior chimeric cell therapy (unless ≥ 3 months after cell infusion).

Trial design

Treatments tested in this trial

  • ICP-248
  • ICP-248
  • ICP-248+Orelabrutinib
  • ICP-248+Orelabrutinib
  • ICP-248 +Rituximab
  • ICP-248+Orelabrutinib
  • ICP-248+Orelabrutinib+Rituximab

Treatment groups

191 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov