A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms (NCT06618001)
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta
- Vancouver General Hospital — Vancouver, British Columbia
- Princess Margaret Hospital — Toronto, Ontario
- Hosp Clinic de Barcelona — Barcelona,
- Hosp Univ Fund Jimenez Diaz — Madrid,
- Clinica Univ. de Navarra — Pamplona,
- Addenbrookes Hospital — Cambridge,
- University College London Hospitals — London,
- The Christie NHS Foundation Trust Christie Hospital — Manchester,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia — Duarte, California
- A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy — Duarte, California
- A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies — Birmingham, Alabama
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Explore by condition: All Leukemia, Myeloid, Acute clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.