JNJ-89853413 for Acute Myeloid Leukemia

Recruiting at 8 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Pulmonary compromise, Uncontrolled infection, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-89853413 for individuals with certain types of blood cancer, specifically acute myeloid leukemia (AML) and some high-risk myelodysplastic neoplasms (MDS) that have returned or stopped responding to previous treatments. The study aims to determine a safe and effective dose while assessing the treatment's efficacy. It targets those diagnosed with relapsed or refractory AML or MDS, meaning their condition has returned or does not respond to existing treatments. Participants should not have major lung issues or active infections. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JNJ-89853413 is likely to be safe for humans?

Research shows that JNJ-89853413 is a new treatment being tested for safety and patient tolerance. This study targets individuals with relapsed or hard-to-treat acute myeloid leukemia (AML) and certain types of myelodysplastic neoplasms (MDS). Since the study is in its early stages, the main goal is to observe patient responses and determine the safest dose.

As one of the first studies in humans, detailed safety information is not yet available. However, early-phase trials are designed to closely monitor participant reactions to identify any side effects.

Prospective participants should know that the researchers are committed to ensuring the treatment's safety while gathering more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-89853413 for treating Acute Myeloid Leukemia (AML) because it introduces a novel approach compared to existing therapies like chemotherapy and targeted drugs such as FLT3 inhibitors. While most current treatments work by broadly killing rapidly dividing cells, JNJ-89853413 targets specific pathways involved in the leukemia cell survival and proliferation, potentially reducing damage to healthy cells. This unique mechanism may offer a more effective and less toxic alternative, giving hope for better outcomes in AML patients.

What evidence suggests that JNJ-89853413 might be an effective treatment for acute myeloid leukemia?

Research has shown that JNJ-89853413, the investigational treatment in this trial, may help treat acute myeloid leukemia (AML) by specifically targeting and killing cancer cells. In lab studies, it effectively attacked cancer cells from AML patients. Importantly, it did not harm healthy blood-forming cells, suggesting it might only target the cancer. Although human studies provide limited information, these early results indicate that JNJ-89853413 could be a promising treatment for AML that has returned or is unresponsive to other treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with acute myeloid leukemia (AML) or high-risk myelodysplastic neoplasms (MDS) that have relapsed or are refractory. Participants must have adequate kidney function, specific laboratory parameters within range, be able to perform daily activities (ECOG status 0-2), and weigh at least 40 kg.

Inclusion Criteria

My AML has returned or is not responding to treatment.

My MDS is relapsed or not responding to treatment and is considered moderate to very high risk.

My kidney function is good, with an eGFR of 40 mL/min or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-89853413 with dose levels escalated sequentially to identify the recommended Phase 2 dose

14 days

Cohort Expansion

Participants receive JNJ-89853413 at the recommended Phase 2 dose to further assess safety, tolerability, and efficacy

Approximately 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-89853413

Trial Overview The study tests JNJ-89853413's safety and tolerability to determine the optimal dose for Phase 2 trials in patients with blood cancers that have returned or stopped responding to treatment. It has two parts: Dose Escalation to find the right dose, and Cohort Expansion to evaluate safety and effectiveness.

How Is the Trial Designed?

Group I: JNJ-89853413 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06618001

A Study of JNJ-89853413 for Relapsed or Refractory Acute ... 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.

2. isrctn.com isrctn.com/ISRCTN16221474

A study of JNJ-89853413 for relapsed or refractory acute ... In this study, researchers want to determine the safety and tolerability of JNJ-89853413 and to identify safe doses in participants with relapsed or refractory ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/550238

A Study of JNJ-89853413 for Relapsed or Refractory Acute ... The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 ...

4. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/oncology/2024/ash/discovery-of-jnj89853413-a-firstinclass-cd33xv2-tcell-engager-for-the-treatment-of-acute-myeloid-leu.pdf

Key Takeaways Conclusions JNJ-89853413 showed potent in vitro cytotoxicity to. AML patient-derived BM blast. JNJ-89853413 induced preferential cancer cells cytotoxicity ...

5. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper203248.html

Discovery of JNJ-89853413, a First-in-Class CD33xVδ2 T- ... JNJ-89853413 showed no impact on the colony forming potential of CD34+ hematopoietic stem and progenitors cells obtained from healthy donors in ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124048018

Discovery of JNJ-89853413, a First-in-Class CD33xVδ2 T- ... We developed JNJ-89853413, a novel first-in-class human bispecific antibody comprising a CD33 arm paired with a high-affinity Vδ2 binder.

7. clinicaltrials.jnj.com clinicaltrials.jnj.com/pt-br/study-detail/NCT06618001?tab=eligibility

A Study of JNJ-89853413 for Relapsed or Refractory Acute ... Inclusion Criteria: - Have a diagnosis, per World Health Organization (WHO) 2022 criteria of: 1. relapsed/refractory acute myeloid leukemia (AML).

8. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-89853413-for-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-neoplas

A Study of JNJ-89853413 for Relapsed or Refractory Acute ... 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])