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

Leukemia, Myeloid, Acute | Myelodysplastic Neoplasms

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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 Location

Princess Margaret Hospital
Princess Margaret Hospital
Toronto, Ontario
Canada

Contact Study Team

Study Sponsored By
Janssen Research & Development, LLC
Participants Required
More Information
Study ID: NCT06618001