100 Participants Needed

JNJ-88549968 for Myeloproliferative Disorder

Recruiting at 23 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What makes the drug JNJ-88549968 unique for treating myeloproliferative disorders?

JNJ-88549968 is likely a novel JAK2 inhibitor, targeting the JAK2-STAT pathway, which is crucial in myeloproliferative disorders. This drug may offer a new approach by specifically inhibiting the JAK2V617F mutation, a common driver in these conditions, potentially providing a more targeted treatment option compared to existing JAK inhibitors.12345

What data supports the effectiveness of the drug JNJ-88549968 for treating myeloproliferative disorders?

JAK inhibitors, like ruxolitinib, have been effective in treating myeloproliferative disorders by reducing symptoms and controlling blood cell levels. These drugs target the JAK/STAT pathway, which is often overactive in these conditions, suggesting that similar treatments could be beneficial.12678

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am at least 18 years old or the legal age of majority where the study is conducted.
My blood disorder is due to a specific CALR mutation.
I can take care of myself and am up and about more than half of my waking hours.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JNJ-88549968 with dose escalation to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule based on safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy

Approximately 5 weeks
Multiple visits (in-person)

Dose Expansion

Participants receive JNJ-88549968 at the RP2D regimen determined in dose escalation

Up to 2 years
Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-88549968
Trial Overview 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).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Dose Escalation (Part 1) and Dose Expansion (Part 2)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

The study analyzed 60 cases of myeloproliferative neoplasms (MPN) with both JAK2 V617F and BCR-ABL mutations, highlighting that these mutations can coexist, particularly in patients with chronic myelogenous leukemia (CML).
It was found that polycythemia vera (PV) was the most common type of MPN associated with these mutations, emphasizing the importance of simultaneous testing for both mutations to ensure accurate diagnosis and treatment planning.
[Analysis of Clinical Characteristics of JAK2 V617F and BCR-ABL Double-Mutant Myeloproliferative Neoplasms].Yan, J., Ding, YW., Wang, PY., et al.[2022]
Crizotinib effectively suppresses the proliferation of cells and JAK/STAT signaling in myeloproliferative neoplasms (MPN), showing preclinical efficacy in patient samples and mouse models with JAK2 mutations.
The combination of crizotinib with JAK inhibitors like ruxolitinib can overcome resistance to treatment, suggesting that crizotinib may be a promising option for patients with MPN who experience persistence with JAK inhibitors.
Crizotinib Has Preclinical Efficacy in Philadelphia-Negative Myeloproliferative Neoplasms.Gurska, LM., Okabe, R., Schurer, A., et al.[2023]
JAK inhibitors, particularly ruxolitinib, have become essential in treating classical BCR-ABL1-negative myeloproliferative neoplasms (MPN) like primary myelofibrosis (PMF) and polycythemia vera (PV), showing significant efficacy over the past several years.
Newer JAK inhibitors, such as pacritinib and Itacitinib, are being explored for their potential benefits, including reduced side effects and improved treatment outcomes, particularly in managing anemia associated with myelofibrosis.
The BCR-ABL1-negative myeloproliferative neoplasms: a review of JAK inhibitors in the therapeutic armamentarium.Griesshammer, M., Sadjadian, P.[2021]

Citations

[Analysis of Clinical Characteristics of JAK2 V617F and BCR-ABL Double-Mutant Myeloproliferative Neoplasms]. [2022]
Crizotinib Has Preclinical Efficacy in Philadelphia-Negative Myeloproliferative Neoplasms. [2023]
The BCR-ABL1-negative myeloproliferative neoplasms: a review of JAK inhibitors in the therapeutic armamentarium. [2021]
JAK2 inhibitors: A reality? A hope? [2023]
The role of JAK2 inhibitors in MPNs 7 years after approval. [2021]
JAK2 mutants (e.g., JAK2V617F) and their importance as drug targets in myeloproliferative neoplasms. [2023]
Discovery and evaluation of ZT55, a novel highly-selective tyrosine kinase inhibitor of JAK2V617F against myeloproliferative neoplasms. [2020]
Detection of mutations in JAK2 exons 12-15 by Sanger sequencing. [2016]
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