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A Phase II/III Study of ICP-248 in Combination with Orelabrutinib in Patients with Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial Profile

A Phase II/III Study of ICP-248 in Combination with Orelabrutinib in Patients with Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 28 Mar 2025

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At a glance

  • Drugs Mesutoclax (Primary) ; Orelabrutinib (Primary) ; Immunotherapies
  • Indications Chronic lymphocytic leukaemia
  • Focus Adverse reactions; Registrational
  • Sponsors InnoCare Pharma

Most Recent Events

  • 28 Mar 2025 According to an InnoCare Pharma media release, company announced that the first patient has been dosed in the Phase III registrational trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China
  • 17 Feb 2025 According to an InnoCare Pharma media release, company announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved the registrational Phase III clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor orelabrutinib as a first-line therapy for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients in China.
  • 20 Aug 2024 According to an InnoCare Pharma media release, enrollment of Phase II patients has been completed.

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