A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

ClinicalTrials.gov ID: NCT03915379

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Official title

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-67371244 (Bispecific Antibody Targeting CD33 and CD3), in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of this study are to determine the recommended Phase 2 dose(s) (RP2D) route of administration, schedule and the maximum tolerated dose (MTD) in Part 1 and to determine the safety and tolerability of JNJ-67571244 at the RP2D regimen(s) and to evaluate the preliminary clinical activity of JNJ-67571244 in Part 2.

Study identification

NCT ID: NCT03915379
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 68 participants

Conditions and interventions

Conditions

Interventions

JNJ-67571244 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 28, 2019 (Actual)
Primary completion: Mar 26, 2022 (Actual)
Completion: Mar 28, 2022 (Actual)
Last update posted: May 23, 2025

2019 – 2022

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 8

Facility	City	State	ZIP	Site status
Massachusetts General Hospital	Boston	Massachusetts	02114	—
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	—
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	—
Hackensack University Medical Center	Hackensack	New Jersey	07601	—
NYU Hematology Associates	New York	New York	10016	—
Levine Cancer Institute, Carolinas HealthCare System	Charlotte	North Carolina	28204	—
Sarah Cannon Research Institute	Nashville	Tennessee	37203	—
MD Anderson Cancer Center	Houston	Texas	77030	—
Fred Hutchinson Cancer Research Center	Seattle	Washington	98109	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03915379, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 23, 2025 · Synced Nov 13, 2026