OncoMatch/Clinical Trials/NCT05728658
The Study of ICP-248 in Patients With Mature B-cell Malignancies
Is NCT05728658 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for hematological malignancies.
Treatment: ICP-248 · ICP-248 · ICP-248+Orelabrutinib · ICP-248+Orelabrutinib · ICP-248 +Rituximab · ICP-248+Orelabrutinib · ICP-248+Orelabrutinib+Rituximab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05728658 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous stem cell transplant, chimeric cell therapy, BCL-2 inhibitor disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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