RecruitingPHASE1INTERVENTIONAL

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

This research study is looking at a new medicine called JNJ-95804306 for specific types of blood cancers, including acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL). It's designed for people whose cancer has returned or didn't get better with their usual treatments. The first part of the study focuses on finding a safe and tolerable dose of JNJ-95804306. The second part will then look more closely at its safety and how effectively it fights cancer, either by itself or when given along with standard treatments. The goal is to see if this new medicine could be a helpful option for patients in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

360

Start

13 May 2026

Estimated completion

24 Sep 2032

Hematologic Neoplasms

What is this study about?

This study is about a new potential medicine, called JNJ-95804306, for people with certain types of blood cancer. You might know these as 'hematological malignancies'. These are cancers that affect your blood-forming tissues, such as your bone marrow, or the cells in your immune system. Researchers are focusing on people whose cancer has either come back after treatment (this is called 'relapsed') or hasn't responded to earlier treatments (this is called 'refractory').

The study has two main parts. The first part is like a careful checking phase. It's designed to see how safe the new medicine, JNJ-95804306, is and to figure out what dose is best tolerated by patients. This is really important to make sure that any future treatments are as safe as possible. Scientists want to identify a dose that offers the most benefit with the fewest side effects.

Once a suitable dose is found, the second part of the study begins. Here, more people will receive the new medicine. The main goals are to continue looking at the safety of JNJ-95804306 and to observe how well it works against the cancer. This might involve giving the new medicine on its own, or sometimes alongside other standard treatments you might already be familiar with. The hope is that this new medicine could help patients whose cancer has been difficult to treat with current options.

Key takeaways

This study is testing a new medicine (JNJ-95804306) for specific types of blood cancer.
It's for people whose cancer has returned or didn't respond to previous treatments.
The study aims to find a safe dose and see how well the medicine works.
Participants will have regular check-ups and monitoring by a dedicated medical team.
There are potential benefits (access to new medicine) and risks (unknown side effects) involved.
You can withdraw from the study at any time without affecting your future care.

Who may be eligible?

This study is for adults aged 18 or older. To be part of it, you need to have a specific type of blood cancer that has either come back after treatment or hasn't responded to previous treatments. Your doctor will need to confirm your diagnosis, which could be acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that are considered moderate to very high risk, or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

For most participants, you must have tried and not been helped by standard treatments, or your doctor believes existing treatments are not suitable for you. If you have CLL/SLL, you should have already received at least two different lines of treatment before considering this study. You would also need a fairly good general health status, as measured by a score called ECOG (0-2), and weigh at least 40 kilograms (about 6 stone 4 pounds).

There are also some reasons why you might not be able to join. For instance, if you have a specific type of AML called acute promyelocytic leukemia, or if your cancer has spread to your brain or spinal cord, you would likely not be eligible. Also, severe infections or needing extra oxygen to breathe would prevent you from taking part.

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 a diagnosis of AML, MDS (moderate-high/high/very high risk), or CLL/SLL?
Has your cancer come back or not responded to previous standard treatments?
If you have CLL/SLL, have you already had at least two previous lines of therapy?
Are you able to manage daily activities with little to no difficulty (ECOG performance status 0-2)?
Weigh at least 40 kg (about 6 stone 4 pounds)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a new medicine called JNJ-95804306. The study involves regular visits to the hospital or clinic where doctors and nurses will monitor your health very closely. They'll perform various tests, like blood tests and scans, to see how your body is reacting to the medicine and if the cancer is responding.

In the first part of the study, the dose of JNJ-95804306 you receive might be slowly increased to find the safest and most effective amount. In the second part, you'll receive the dose that was found to be suitable, either on its own or possibly with other standard treatments. The exact schedule of visits and treatments will be explained in detail by the study team.

You will have regular check-ups to assess any side effects you might experience and to track your overall health. The length of time you participate in the study will depend on how you respond to the treatment and your health. Even if you choose to participate, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Potential risks and benefits

Taking part in any medical study has both potential benefits and potential risks. The main benefit here is that you might gain access to a new medicine that isn't widely available yet, which could potentially help your cancer if standard treatments haven't worked well. You would also be closely monitored by a dedicated medical team. However, there are risks involved. Because JNJ-95804306 is a new medicine, all its side effects might not be fully known. You could experience side effects that range from mild to severe, and some could be serious. The medicine might also not work for your cancer. Before making any decision, the study team will explain all known and potential risks in detail, and you'll have plenty of opportunities to ask questions. Remember, joining a study is always your choice, and you are free to withdraw at any time, for any reason, without affecting your future medical care.

Locations (8)

Indiana Blood & Marrow Transplantation
Verified postcode
Indianapolis, United States· Recruiting
Start Midwest
Verified postcode
Grand Rapids, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
Piscataway, United States· Recruiting
NYU Langone Health
Verified postcode
New York, United States· Recruiting
Sarah Cannon Cancer Institute
Verified postcode
Nashville, United States· Recruiting
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
UZ Antwerpen
Verified postcode
Edegem, Belgium· Recruiting
The Christie Nhs Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What kind of cancer is this study for?

This study is for specific blood cancers like acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that have come back or not responded to usual treatments.

What is JNJ-95804306?

JNJ-95804306 is a new medicine being tested in this study to see if it can safely and effectively treat certain blood cancers.

What happens in the first part of the study?

The first part focuses on finding a safe and well-tolerated dose of the new medicine by slowly adjusting the amount given to participants.

Will I receive other treatments during the study?

In the second part, the new medicine might be given on its own or sometimes alongside other standard cancer treatments, depending on the study plan for your specific condition.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your medical care.

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.