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RECRUITING
NCT06150157
PHASE1

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.

Official title: A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-12-20

Completion Date

2028-04-12

Last Updated

2026-03-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

JNJ-88549968

JNJ-88549968 will be administered.

DRUG

Ruxolitinib

For US sites: Ruxolitinib will be administered for participants with MF only.

DRUG

Momelotinib

For US sites: Momelotinib will be administered for participants with MF only.

Locations (31)

City of Hope

Duarte, California, United States

UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center

Aurora, Colorado, United States

Moffit Cancer center

Tampa, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sarah Cannon Cancer Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hopital Saint Louis

Paris, France

CH LYON SUD - Hematology

Pierre-Bénite, France

Universitaetsklinikum der RWTH Aachen

Aachen, Germany

Charite Campus Benjamin Franklin

Berlin, Germany

Med. Universitatsklinik Essen

Essen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Carmel Medical Center

Haifa, Israel

Hadassah University Hospita Ein Kerem

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Policlinico di Milano

Milan, Italy

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

University College London Hospitals Nhs Foundation Trust

London, United Kingdom

Guy's and St Thomas' Hospital

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom