Testing JNJ-89853413 for blood cancers that have not responded to treatment

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

This study is testing a new drug called JNJ-89853413 to see if it can help people with blood cancers like acute myeloid leukemia and higher-risk myelodysplastic neoplasms that haven't responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen Research & Development, LLC (industry)
• Locations: 7 sites (Vancouver, British Columbia and 6 other locations)
• Trial ID: NCT06618001 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of JNJ-89853413 in patients with relapsed or refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic neoplasms (MDS). The study is divided into two parts: the first part focuses on dose escalation to determine the recommended Phase 2 doses, while the second part aims to further assess safety, tolerability, and efficacy in a larger cohort. Participants will be monitored closely for any adverse effects and treatment responses throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with relapsed or refractory AML or higher-risk MDS who meet specific health criteria.

Not a fit: Patients with significant pulmonary issues or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies have shown promise in targeting similar blood cancers, suggesting potential for success with this approach.

Eligibility 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

Where this trial is running

Vancouver, British Columbia and 6 other locations

• Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
• Princess Margaret Hospital — Toronto, Ontario, Canada (RECRUITING)
• Hosp Clinic de Barcelona — Barcelona, Spain (RECRUITING)
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain (RECRUITING)
• Clinica Univ. de Navarra — Pamplona, Spain (RECRUITING)
• University College London Hospitals — London, United Kingdom (RECRUITING)
• The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms