Purpose of this Study
This study has two parts. In the first part, researchers will test different doses of the study drug JNJ-88549968 in people with essential thrombocythemia or myelofibrosis to find the safest dose. In the second part, more participants will receive the selected dose so researchers can further study its safety and how well it works.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults with essential thrombocythemia or myelofibrosis that is considered higher risk or causes significant symptoms, an enlarged spleen, or anemia. They must have not responded to, cannot tolerate, or are not eligible for certain standard treatments. Researchers will evaluate blood counts, disease severity, prior treatments, and overall health to determine eligibility.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new drug called JNJ-88549968 in people with essential thrombocythemia or myelofibrosis. Researchers want to find a safe dose, learn how the drug behaves in the body, and see how the body responds to the treatment.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full 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
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00120617
NCT ID
NCT06150157
Phase
I
Enrollment Status
Pending Open to Enrollment