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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Neoplasms

Treatments: Drug: JNJ-89853413

Study type: Interventional

Funder types: Industry

Identifiers

NCT06618001

89853413AML1001

2024-513199-16-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 1 patient group

JNJ-89853413

Experimental group

Description:

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.

Treatment:

Drug: JNJ-89853413