OncoMatch/Clinical Trials/NCT06378138

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Is NCT06378138 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including ICP-248 and Orelabrutinib for hematologic malignancies.

Phase 2/3RecruitingBeijing InnoCare Pharma Tech Co., Ltd.NCT06378138Data as of May 2026

Treatment: ICP-248 · Orelabrutinib — Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Check if I qualify

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

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic treatment

Exception: emergency pretreatment to reduce white blood cells and relieve leukostasis

Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis

Cannot have received: allogeneic stem cell transplantation

History of allogeneic stem cell transplantation

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.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify