Trial Title:
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
NCT ID:
NCT06150157
Condition:
Myeloproliferative Disorders
Essential Thrombocythemia
Neoplasms
Myelofibrosis
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-88549968
Description:
JNJ-88549968 will be administered.
Arm group label:
Dose Escalation (Part 1) and Dose Expansion (Part 2)
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known allergies, hypersensitivity, or intolerance to the excipients of the study
treatment
- Concurrent or recently diagnosed or treated malignancies present at the time of
participant screening. Exceptions are squamous and basal cell carcinoma of the skin,
carcinoma in situ of the cervix, and any malignancy that is considered cured or has
minimal risk of recurrence within 1 year of first dose of study treatment in the
opinion of both the investigator and sponsor's medical monitor. Participants cured
of another malignant disease with no sign of relapse greater than or equal to (>=) 3
years after treatment ended are allowed to enter the study
- Prior solid organ transplantation
- Either of the following regarding hematopoietic stem cell transplantation:
1. Prior treatment with allogenic stem cell transplant less than or equal to (<=)
6 months before the first dose of JNJ-88549968 or
2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant
therapy
- History of clinically significant cardiovascular disease within 6 months prior to
the first dose of study treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Cancer Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre University Health Network
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Hopital Saint Louis
Address:
City:
Paris
Zip:
75475
Country:
France
Status:
Recruiting
Facility:
Name:
CH LYON SUD - Hematology
Address:
City:
Pierre Benite Cedex
Zip:
69495
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum der RWTH Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Charite Campus Benjamin Franklin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Recruiting
Facility:
Name:
Medizinische Hochschule Hannover
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Germans Trias I Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Clinico Univ. de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
University College London Hospitals Nhs Foundation Trust
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Start date:
December 20, 2023
Completion date:
November 19, 2026
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150157
