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RecruitingLast updated: 2 June 2025

This study is recruiting people with relapsed or refractory Acute Myeloid Leukaemia (AML) or Myelodysplastic Neoplasms (MPN) to assess the effective dose, safety and tolerability of a new medicine called JNJ-90189892A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

You may be eligible for this study if you have relapsed or refractory (R/R) acute myeloid leukaemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (a type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment). 

This study has two parts. The purpose of Part 1 (Dose Escalation) is to assess the effective dose (recommended Phase 2 dose[s] [RP2D]) that can be safely administered, and dosing regimens of JNJ-90189892. In this part, participants will recieve JNJ-90189892 and the dose levels will be escalated sequentially based on the decisions of the safety evaluation team until the RP2D has been identified.

The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy of JNJ-90189892 in participants with R/R AML or high-risk types of MDS. Participants in Part 2 will receive JNJ-90189892 at the RP2D determined in Part 1.

 

Conditions

This trial is treating people with relapsed or refractory acute myeloid leukaemia or moderate high, high, or very high-risk myelodysplastic neoplasms

Eligibility

Inclusion

  • Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Acute myeloid leukemia (AML) or (b) Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
  • Body weight that is greater than or equals to (>=) 40 kg
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 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) computed with the calculator on the CKD-EPI website
  • Participants must have laboratory parameters in the required range

Exclusion

  • Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
  • Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
  • Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients
  • Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
  • Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment
  • Has known active central nervous system involvement

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06651229 *
  • 90189892AML1001; 90189892AML1001; 2024-514341-10-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

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