Your session is about to expire
← Back to Search
Monoclonal Antibodies
JNJ-88549968 for Myeloproliferative Disorder
Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, JNJ-88549968, to find the safest and most effective dose for patients. It aims to determine the best dosing schedule and ensure the drug's safety.
Who is the study for?
This trial is for adults with a specific mutation called CALR in their blood cells, leading to conditions like thrombocytosis and myelofibrosis. They should be able to perform daily activities with ease or only have slight limitations (ECOG <=2). The study excludes details not provided.
What is being tested?
The trial tests JNJ-88549968's safety and the best dose for treating certain blood disorders. It has two parts: finding the right dose (Dose Escalation) and then seeing how safe it is at that dose (Cohort Expansion).
What are the potential side effects?
Specific side effects of JNJ-88549968 are not listed, but generally, such treatments may cause fatigue, nausea, bruising or bleeding risks, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal age of majority where the study is conducted.
Select...
My blood disorder is due to a specific CALR mutation.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 and 2: Number of Participants with Adverse Events (AEs)
Part 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Secondary study objectives
Part 1 and 2: Complete Response (CR) Rate
Part 1 and 2: Duration of Response (DOR)
Part 1 and 2: Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation (Part 1) and Dose Expansion (Part 2)Experimental Treatment1 Intervention
In dose escalation (Part 1), participants will receive 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), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Myeloproliferative Disorders (MPNs) include JAK inhibitors (e.g., ruxolitinib), interferons, and hydroxyurea. JAK inhibitors work by blocking the Janus kinase pathway, which is often overactive in MPNs due to mutations like JAK2 V617F, thereby reducing abnormal cell proliferation and alleviating symptoms.
Interferons modulate the immune system to target malignant cells, while hydroxyurea inhibits DNA synthesis, reducing the production of abnormal blood cells. These treatments are crucial for MPN patients as they help manage symptoms, reduce the risk of complications like thrombosis, and potentially slow disease progression.
The study of JNJ-88549968, which aims to determine its safety and optimal dosing, is important as it may offer a new targeted therapy option, potentially improving patient outcomes by providing a more effective or better-tolerated treatment.
Targeted therapy of polycytemia vera patients.Incidence, Survival and Prevalence Statistics of Classical Myeloproliferative Neoplasm in Korea.Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
Targeted therapy of polycytemia vera patients.Incidence, Survival and Prevalence Statistics of Classical Myeloproliferative Neoplasm in Korea.Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,398,207 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
770 Previous Clinical Trials
3,973,947 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger