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A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
Sponsor: Janssen Research & Development, LLC
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
JNJ-88549968
JNJ-88549968 will be administered.
Ruxolitinib
For US sites: Ruxolitinib will be administered for participants with MF only.
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