Clinical Trial Goal
To find out:
- The highest dose of JNJ-88549968 that's safe to give
- If JNJ-88549968 is safe and works well to treat MPNs with CALR mutation
You may be able to join this trial if you:
- Are 18 years or older
- Have one of the following:
- Essential thrombocythemia (ET)
- Myelofibrosis
- Have disease cells with CALR mutation. Your doctor can tell you this
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 6 months
- Do not have graft versus host disease (GVHD) that requires immunosuppressants
- Have not been treated with a JAK inhibitor, like ruxolitinib. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
JNJ-88549968 is a bispecific T-cell engager (BiTE) antibody that targets CALR on certain cells.
Momelotinib and ruxolitinib are small molecule inhibitors that block JAK1 and JAK2 in certain cells. This means the drugs try to stop certain T-cell signals that can lead to tissue damage.
You’ll get:
Momelotinib and ruxolitinib are small molecule inhibitors that block JAK1 and JAK2 in certain cells. This means the drugs try to stop certain T-cell signals that can lead to tissue damage.
You’ll get:
- JNJ-88549968 – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Momelotinib - Patients with myelofibrosis only - A pill that you take by mouth
- Ruxolitinib - Patients with myelofibrosis only - A pill that you take by mouth
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.
The Food and Drug Administration (FDA) has not yet approved JNJ-88549968.
Locations
Sponsors
lead: Janssen Research & Development, LLC
