RecruitingPHASE1INTERVENTIONAL

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

This research is looking into a new medication called JNJ-88549968 for adults living with certain blood cancers known as myeloproliferative neoplasms (MPNs), specifically those with a CALR gene change. The study has two main goals: firstly, to understand the safety of the new medicine and find the best dose to use; and secondly, to see how people respond to this dose over time. For some people, especially in the US, the study will also look at using JNJ-88549968 alongside other established MPN treatments like ruxolitinib or momelotinib. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in humans.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

220

Start

20 Dec 2023

Estimated completion

12 Apr 2028

Neoplasms

What is this study about?

This study is investigating a new medication called JNJ-88549968. It's designed for people who have specific types of blood cancers known as myeloproliferative neoplasms (MPNs), which include conditions like essential thrombocythemia (ET) or myelofibrosis (MF). Crucially, participants must have a particular genetic change in their CALR gene, which is often found in these conditions.

The main purpose of this early-stage research is to understand the new medicine better. This involves checking how safe it is for people and finding the most effective dose to use. Researchers will also look at how the body handles the medicine and how it affects the MPN. For some individuals, particularly in the US, the study will also explore using JNJ-88549968 together with other treatments already used for MF, such as ruxolitinib or momelotinib.

Developing new treatments is vital for conditions like MPNs. This study aims to gather important information that could help decide if JNJ-88549968 has the potential to become a new standard treatment option in the future. The findings from this study will help guide further research into this medicine.

Key takeaways

This study is testing a new medicine (JNJ-88549968) for specific CALR-mutated MPNs (ET or MF).
Its main goal is to find a safe dose and understand how the medicine works.
It's an early-stage (Phase 1) study, focusing on safety and dosage.
You must be an adult with a confirmed CALR gene change to be eligible.
Participation involves regular clinic visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. A key requirement is that your essential thrombocythemia (ET) or myelofibrosis (MF) must be linked to a specific change in your CALR gene. Your doctor will need to confirm this.

You also need to be broadly well enough to take part. This means your general health and fitness levels, as assessed by a quick grading system (ECOG), should be 2 or below. There are also specific criteria related to the risk level of your ET or MF that your study doctor will check.

There are also some reasons why you might not be able to join. For example, if you have certain allergies, other cancers that are active or were recently treated (with some exceptions like certain skin cancers), or if you've recently had a solid organ transplant or a stem cell transplant. Also, serious heart conditions within the last six months would prevent participation. Your study doctor will go through all these details with you carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have essential thrombocythemia (ET) or myelofibrosis (MF) with a CALR gene mutation?
Is your general health good enough for a clinical trial (ECOG score of 2 or less)?
Have you discussed any other recent cancers, allergies, or serious heart conditions with your doctor?
Have you not had a recent solid organ or stem cell transplant within specific timeframes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the new study medicine, JNJ-88549968. In some cases, you might also receive it alongside other existing treatments like ruxolitinib or momelotinib. You'll have regular visits to the clinic so the study team can monitor your health and how you respond to the treatment. This will involve regular check-ups, blood tests, and other assessments.

The study is divided into two main parts. The first part focuses on finding the safest and most suitable dose of JNJ-88549968. Once that dose is identified, the second part will involve more people receiving that specific dose to further assess its safety and how effectively it works. The total duration of your participation will vary depending on which part of the study you are in and how you respond, but the study team will be able to give you a clearer idea of the expected time commitment, including follow-up appointments.

Potential risks and benefits

As with any new medicine, there are potential benefits and potential risks to consider. A potential benefit of participating is accessing a new treatment that isn't widely available yet, which might help your condition. However, it's important to remember that this is an early-stage study, and it's not guaranteed that the new medicine will improve your health. There could be side effects from the study medicine, and these will be carefully explained to you by the study team. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope
Verified postcode
Duarte, United States· Recruiting
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center
Verified postcode
Aurora, United States· Recruiting
Moffit Cancer center
Verified postcode
Tampa, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Recruiting
Levine Cancer Institute
Verified postcode
Charlotte, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Sarah Cannon Cancer Institute
Verified postcode
Nashville, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Princess Margaret Cancer Centre University Health Network
Verified postcode
Toronto, Canada· Recruiting
Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What type of gene change is important for this study?

This study is specifically for people whose blood cancer (ET or MF) has a particular change in their CALR gene.

Is the new medicine, JNJ-88549968, already approved for use?

No, JNJ-88549968 is an investigational medicine, meaning it's still being tested in clinical trials and is not yet approved for general use.

What does 'Phase 1' mean for a clinical trial?

Phase 1 studies are the first step in testing a new medicine in humans. They mainly focus on checking its safety and finding the right dose.

Will I definitely receive the new medicine?

Yes, all participants in this study will receive the new investigational medicine, JNJ-88549968.

How long will I be in the study?

The length of your participation will depend on how you respond to the treatment and the study part you are in. The study team will provide more specific details.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.