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

NCT06618001 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 89853413AML10012024-513199-16-00
• Study Type: interventional
• Target: 115
• Locations: 3 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse events (AEs) by Severity

  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.

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

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

  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.

  14 days

Secondary Outcomes (11)

• Serum Concentration of JNJ- 89853413

  Approximately 2.5 years

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

  Approximately 2.5 years

• Maximum Serum Concentration (Cmax) of JNJ-89853413

  Approximately 2.5 years

• Trough Observed Serum Concentration (Ctrough) of JNJ-89853413

  Approximately 2.5 years

• Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413

  Approximately 2.5 years

Study Arms (1)

JNJ-89853413

EXPERIMENTAL

Participants will receive JNJ-89853413 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89853413 at the RP2D determined in Part 1.

Drug: JNJ-89853413

Interventions

JNJ-89853413 DRUG

JNJ-89853413 will be administered.

JNJ-89853413

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (9)

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Clinica Univ. de Navarra

Pamplona, 31008, Spain

RECRUITING

Addenbrookes Hospital

Cambridge, Cb2 2qq, United Kingdom

RECRUITING

University College London Hospitals

London, W1T 7HA, United Kingdom

RECRUITING

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): January 12, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (3); CA (3); ES (3)