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A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Recruiting
18 years and older
All
Phase 1

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Overview

The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose[s] (RP2D[s]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.

Eligibility

Inclusion Criteria:

  • Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
    1. relapsed/refractory acute myeloid leukemia (AML)
    2. relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
  • Body weight greater than or equals to (>=) 40 kilograms (kg)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams per minute (mL/min)
  • Participants must have laboratory parameters in the required range

Exclusion Criteria:

  • Has a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation
  • Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
  • Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413
  • Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
  • Has known active central nervous system involvement

Study details
    Leukemia
    Myeloid
    Acute
    Myelodysplastic Neoplasms

NCT06618001

Janssen Research & Development, LLC

30 July 2025

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