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OncoMatch/Clinical Trials/NCT05728658

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

Is NCT05728658 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for hematological malignancies.

Phase 1RecruitingBeijing InnoCare Pharma Tech Co., Ltd.NCT05728658Data as of May 2026

Treatment: ICP-248 · ICP-248 · ICP-248+Orelabrutinib · ICP-248+Orelabrutinib · ICP-248 +Rituximab · ICP-248+Orelabrutinib · ICP-248+Orelabrutinib+RituximabA 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received:

Relapsed disease or refractory disease

Cannot have received: autologous stem cell transplant

Exception: unless ≥ 3 months after transplant

Prior autologous stem cell transplant (unless ≥ 3 months after transplant)

Cannot have received: chimeric cell therapy

Exception: unless ≥ 3 months after cell infusion

prior chimeric cell therapy (unless ≥ 3 months after cell infusion)

Cannot have received: BCL-2 inhibitor

Exception: Disease recurrence/progression after stopping or ending BCL-2 inhibitor therapy is acceptable

Received a BCL-2 inhibitor prior to initial use of the investigational drug and did not achieve disease remission or disease recurrence/progression on treatment

Cannot have received: allogeneic stem cell transplantation

A history of allogeneic stem cell transplantation

Cannot have received: anti-cancer therapy

Exception: within 14 days prior to the first dose of the investigational product

Anti-cancer therapy within 14 days prior to the first dose of the investigational product

Lab requirements

Blood counts

adequate hematologic function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

adequate cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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