Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Claire Harrison


Dr Medical Information and Product Information Enquiry
+44 (0)800 731 8540, (0)1494 567 444
Medinfo@its.jnj.com


Ms Florence Baluwa
None provided
JanssenUKRegistryQueries@its.jnj.com


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - A study of JNJ-88549968 for the treatment of calreticulin (CALR)-mutated myeloproliferative neoplasms
Back

A study of JNJ-88549968 for the treatment of calreticulin (CALR)-mutated myeloproliferative neoplasms

Recruiting

Open to: All Genders

Age: Mixed

$location.addressLine3

Medical Conditions

Calreticulin (CALR)-mutated myeloproliferative neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Myeloproliferative neoplasms (MPNs) are rare blood cancers causing abnormal blood cell growth in bone marrow. Essential thrombocythemia (ET) is an MPN where excessive platelet production increases clotting and bleeding risk, as well as a risk of marrow fibrosis (injury/damage) and even leukaemia. Myelofibrosis (MF) involves bone marrow fibrosis (injury/damage), low blood counts and an enlarged spleen. MPNs may cause complications like blood clots and heart attacks due to blood cell overproduction as well as an increased risk of infection because the blood cells do not work properly. Both ET and MF may transform into a serious, uncontrolled condition called leukaemia. Drug JNJ-88549968 is a T-cell redirecting antibody* that targets CD3 antigen on T lymphocytes (immune cells) and mutant forms of calreticulin (CALRmut) found on MPN-associated cancer cells. The drug links cancer cells and T lymphocytes of the immune system, with the intention to clear the cancer cells from the body.*Antibody is a type of protein produced by the body’s immune system that can recognize and bind to antigens (specific targets) in the body. The study aims to find the recommended phase II dose (RP2D) and dosing schedule for drug JNJ-88549968 in Part 1 and further test the safety of JNJ-88549968 at RP2D in Part 2.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

11 Dec 2023 12 May 2026

The study comprises 2 parts:
Part 1: Participants will receive JNJ-88549968 to find the optimal drug dose (RP2D) and schedule. This will be determined by assessing its safety, how the body processes it, how it affects the body and its initial effectiveness in different dosing regimens. Part 2: Participants will receive JNJ-88549968 at the RP2D regimen(s) determined in Part 1. Safety and effectiveness data will be regularly reviewed. Safety assessments will include physical examination, vital signs, clinical laboratory tests, ECOG performance status, electrocardiograms, AE monitoring and DLTs Total study duration will be up to approximately 2 years.


Patients with CALRmut MPN are diagnosed as either ET or MF

You can take part if:



You may not be able to take part if:


Any potential participant who meets any of the following criteria will be excluded from participating in the study:1. Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment2. Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of the first dose of study treatment in the opinion of both the investigator and sponsor’s medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (>=) 3 years after treatment ended are allowed to enter the study3. Prior solid organ transplantation- Either of the following regarding hematopoietic stem cell transplantation:3.1. Prior treatment with allogenic stem cell transplant less than or equal to (<=) 6 months before the first dose of JNJ-88549968 or 3.2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy4. History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • -
    -

Participants may not receive any benefit from taking part in this study, but the information that is learned from the study may help people with CALR-mutated MPN in the future.
This is a first-in-human study which means that JNJ-88549968 has not been given to people before.
The expected risks for JNJ-88549968, based on how the drug works and results from laboratory studies are listed as thrombocytopenia, infection, tumour lysis syndrome (TLS), cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), injection site reactions (ISR), systemic administration-related reactions (sARRs), immune-related adverse events (irAEs).
The participant information sheet and informed consent form, which will be signed by every participant agreeing to take part in the study, includes a detailed section outlining the risks of participating in the study. Participants may have none, some, or all of the possible side effects listed, and they may be mild, moderate, or severe. To minimise the risk associated with taking part, participants are frequently reviewed for any side effects and other medical events. If they have any side effects and are worried about them, or have any new or unusual symptoms, participants will be encouraged to talk with their study doctor. The study doctor will also be looking out for side effects and will provide appropriate medical care. There may also be side effects that the researchers do not expect or do not know about and that may be serious. Many side effects go away shortly after the intervention ends. However, sometimes side effects can be serious, long-lasting, or permanent. If a severe side effect or reaction occurs, the study doctor may need to stop the procedure. The study doctor will discuss the best way of managing any side effects with participants. There is always a chance that an unexpected or serious side effect may happen. This can happen to people who take this or any other drug.

Dr Medical Information and Product Information Enquiry
+44 (0)800 731 8540, (0)1494 567 444
Medinfo@its.jnj.com


Ms Florence Baluwa
None provided
JanssenUKRegistryQueries@its.jnj.com


Prof Claire Harrison



The study is sponsored by Janssen Research & Development, LLC and funded by Janssen Research and Development.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN79300015

Or CPMS 57124

Last updated 24 June 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top