Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06618001

A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Myelodysplastic Neoplasms Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

JNJ-89853413

Drug

JNJ-89853413 will be administered.

Primary outcomes

  1. Number of Participants with Adverse events (AEs) by Severity

    Time frame: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)

    Time frame: 14 days

    Participants with dose-limiting toxicity (DLT) will be assessed. DLT is defined as any toxicity that requires discontinuation of treatment, any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4) and Hematologic Toxicity.

Secondary outcomes

  1. Serum Concentration of JNJ- 89853413

    Time frame: Approximately 2.5 years

    Serum samples will be analyzed to determine concentrations of JNJ-89853413 using a validated immunoassay method.

  2. Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413

    Time frame: Approximately 2.5 years

    AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.

  3. Maximum Serum Concentration (Cmax) of JNJ-89853413

    Time frame: Approximately 2.5 years

    Cmax is defined as maximum serum concentration of JNJ-89853413.

  4. Trough Observed Serum Concentration (Ctrough) of JNJ-89853413

    Time frame: Approximately 2.5 years

    Ctrough is the trough observed serum concentration of JNJ-89853413.

  5. Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413

    Time frame: Approximately 2.5 years

    Participants with anti JNJ-89853413 antibodies will be analyzed by a bridging electrochemiluminescence (ECL) enzyme linked immune assay.

  6. Complete Response (CR) in Acute Myeloid Leukemia (AML)

    Time frame: Approximately 2.5 years

    CR is achieved when a participant has a best response of CR (complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ENL) 2022 criteria.

  7. Overall Response (OR) in Myelodysplastic Neoplasms (MDS)

    Time frame: Approximately 2.5 years

    OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery [CRL]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.

  8. Complete Response in MDS

    Time frame: Approximately 2.5 years

    CR is achieved when a participant has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.

  9. Duration of Response (DOR)

    Time frame: Approximately 2.5 years

    DOR is defined for responsders only, as time from date of initial documentation of a response to the first documented evidence of no reponse, disease progression, relapse, initation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant [HSCT]), or death, whichever comes first.

  10. Time to response (TTR)

    Time frame: Approximately 2.5 years

    TTR is defined for responders only, as the time from the first dose of study drug to first qualifying response.

  11. Number of Participants Achieving Transfusion independence

    Time frame: Approximately 2.5 years

    Transfusion independence is defined as the absence of red blood cell (RBC) and platelet transfusions for 8 weeks or longer after starting study treatment for participants with AML and 16 weeks or longer for participants with MDS.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.