NCT06618001

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Neoplasms

Interventions

Type	Name	Description
DRUG	JNJ-89853413	JNJ-89853413 will be administered.

Timeline

• Start date: 2025-01-14
• Primary completion: 2027-07-15
• Completion: 2028-01-12
• First posted: 2024-10-01
• Last updated: 2026-04-13

Locations

9 sites across 3 countries: Canada, Spain, United Kingdom

Regulatory

• FDA-regulated drug study