JNJ-89853413 for Acute Myeloid Leukemia

Recruiting at3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Janssen Research & Development, LLC

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• JNJ-89853413 (CAR T-cell Therapy)

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.

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires