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Leukemia, Myeloid, AcutePhase 1NCT06618001

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

A Phase 1 study testing JNJ-89853413 in people with Leukemia, Myeloid, Acute and Myelodysplastic Neoplasms, run by Janssen Research & Development, LLC at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-89853413
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
9 sitesin 3 countries
Study dates
14 Jan 2025to 1 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

Canada3 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Spain3 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Clinica Univ. de Navarra

    Pamplona, 31008

Other trials in Spain

United Kingdom3 sites

  • Addenbrookes Hospital

    Cambridge, Cb2 2qq

  • University College London Hospitals

    London, W1T 7HA

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Phase 1, First-in-Human, Dose Escalation 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.

Being tested
JNJ-89853413
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-89853413Drug

    JNJ-89853413 will be administered.

Study groups in NCT06618001
Study groupRoleWhat they receive
JNJ-89853413ExperimentalParticipants 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.
Receives: Drug: JNJ-89853413

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 14 days

Secondary outcomes (11)

  1. Serum Concentration of JNJ- 89853413

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

    Measured: Approximately 2.5 years

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

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

    Measured: Approximately 2.5 years

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

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

    Measured: Approximately 2.5 years

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

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

    Measured: Approximately 2.5 years

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

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

    Measured: Approximately 2.5 years

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

    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.

    Measured: Approximately 2.5 years

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

    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.

    Measured: Approximately 2.5 years

  8. Complete Response in MDS

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

    Measured: Approximately 2.5 years

  9. Duration of Response (DOR)

    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.

    Measured: Approximately 2.5 years

  10. Time to response (TTR)

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

    Measured: Approximately 2.5 years

  11. Number of Participants Achieving Transfusion independence

    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.

    Measured: Approximately 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start14 Jan 2025
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06618001
Sponsor's protocol ID
89853413AML1001
Other IDs
89853413AML1001, 2024-513199-16-00
Status last verified
Nov 2026
First submitted
26 Sep 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-89853413 in people with Leukemia, Myeloid, Acute and Myelodysplastic Neoplasms, run by Janssen Research & Development, LLC at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06618001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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