Find Essential Thrombocythemia Clinical Trials Near You
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
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent
• Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
• Participants with ET and MF with risk characteristics as described in the protocol
• Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2
• For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor
Locations
United States
California
City of Hope
RECRUITING
Duarte
Colorado
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
RECRUITING
Aurora
Florida
Moffit Cancer center
RECRUITING
Tampa
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Sarah Cannon Cancer Institute
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Canada
Jewish General Hospital
RECRUITING
Montreal
Princess Margaret Cancer Centre University Health Network
RECRUITING
Toronto
France
Hopital Saint Louis
RECRUITING
Paris
CH LYON SUD - Hematology
RECRUITING
Pierre-bénite
Germany
Universitaetsklinikum der RWTH Aachen
RECRUITING
Aachen
Charite Campus Benjamin Franklin
RECRUITING
Berlin
Med. Universitatsklinik Essen
RECRUITING
Essen
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Regensburg
RECRUITING
Regensburg
Israel
Carmel Medical Center
RECRUITING
Haifa
Hadassah University Hospita Ein Kerem
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Policlinico Sant'Orsola Malpighi
RECRUITING
Bologna
Policlinico di Milano
RECRUITING
Milan
Spain
Hosp. Univ. Germans Trias I Pujol
RECRUITING
Badalona
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
United Kingdom
Guy's and St Thomas' Hospital
RECRUITING
London
University College London Hospitals Nhs Foundation Trust
RECRUITING
London
Churchill Hospital
RECRUITING
Oxford
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2023-12-20
Estimated Completion Date:2028-04-12
Participants
Target number of participants:220
Treatments
Experimental: Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)
In dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. In dose expansion (Part 2, Part 2b \[US only\]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b \[US only\]).