RecruitingPhase 1NCT06618001

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

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms


Sponsor

Janssen Research & Development, LLC

Enrollment

115 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing JNJ-89853413 — a new targeted therapy — in people with acute myeloid leukemia (AML) or myelodysplastic neoplasms (MDS) that have relapsed (come back) or are refractory (not responding) to prior treatments. Both are serious blood cancers where the bone marrow produces abnormal cells. **You may be eligible if...** - You have been diagnosed with relapsed or refractory AML or moderate-high to very high risk MDS per WHO 2022 criteria - You weigh at least 40 kg - You are in reasonably good health (ECOG score 0–2) - Your kidneys are functioning adequately (eGFR ≥ 40 mL/min) - Your blood test results are within the required ranges **You may NOT be eligible if...** - You have significant lung problems or breathing difficulties - You have uncontrolled infections or certain other serious health conditions - Your kidney or other organ function does not meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-89853413

JNJ-89853413 will be administered.


Locations(9)

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Addenbrookes Hospital

Cambridge, United Kingdom

University College London Hospitals

London, United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06618001


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