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Brief Title: A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
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
Study ID: NCT06150157
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, 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
University Health Network UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital Saint Louis, Paris, , France
CH LYON SUD - Hematology, Pierre Benite Cedex, , France
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR