NCT06618001CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 26 Sept 2024
- Start date
- 14 Jan 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT06618001
- EU CT number
- 2024-513199-16-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 64
- From 14 Jan 2025 to the primary completion date, 1 Sept 2026
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
Other illness
- 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
Other
- Has known active central nervous system involvement
Who the study is looking for
- Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
- relapsed/refractory acute myeloid leukemia (AML)
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust - Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.