A study of JNJ-95804306 for relapsed or refractory hematological malignancies
Blood cancers, such as leukaemia and lymphoma, occur when blood cells grow abnormally. In some cases, the cancer comes back after treatment (relapses) or stops responding to treatment (refractory). When standard treatments are no longer working, new options are urgently needed. This Phase 1 trial tests an experimental medicine named JNJ-95804306. It works by breaking down a protein that helps cancer cells survive, encouraging the cancer cells to die off. Because this is a 'first-in-human' study, the main goal is to find out if the drug is safe, what the right dose is, and what side effects it might cause. Participants will take JNJ-95804306 either on its own or alongside standard cancer medicines. Doctors will monitor participants very closely with regular hospital visits, blood tests, and heart checks to protect their health and track how the treatment works.
At a glance
What is this study about?
Blood cancers, including acute myeloid leukaemia (AML), myelodysplastic syndromes (MDS), and chronic lymphocytic leukaemia (CLL), affect the way your body makes healthy blood cells. While standard treatments often help, sometimes the cancer does not go away or returns after an initial improvement. When standard therapies have been exhausted, clinical trials explore whether new medicines can offer another path forward.
This study focuses on a new drug called JNJ-95804306. Inside many blood cancer cells, there is a specific protein that acts like a shield, stopping the unhealthy cells from naturally dying. JNJ-95804306 is designed to target and break down this protective protein. By removing this shield, the medicine aims to trigger the death of cancer cells and slow down the disease.
Because this is a Phase 1 study, it is the first time JNJ-95804306 is being given to people. The primary aim is not yet to prove how well it cures the disease, but rather to check its safety, understand how the human body processes it, and work out the safest, most effective dose for future research. Researchers will study the drug on its own and in combination with current standard treatments.
Key takeaways
- Tests a new targeted drug (JNJ-95804306) for blood cancers that have returned or stopped responding to treatment.
- First-in-human trial focused on finding the safest dose and identifying side effects.
- Open to eligible adults with AML, high-risk MDS, CLL, SLL, or NHL who have exhausted standard options.
- Requires frequent hospital visits for close health and safety monitoring.
- Participation is entirely voluntary, and you can leave the study at any time.
Who may be eligible?
This trial is for adults (aged 18 or over, or the legal age of consent) who have specific types of blood cancer, including acute myeloid leukaemia (AML), high-risk myelodysplastic syndromes (MDS), chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma (NHL).
To be eligible, your cancer must be relapsed (has come back) or refractory (has stopped responding to treatment), and you must have already tried standard treatments or have no other approved treatment options available that your doctor feels are right for you.
Participants must also weigh at least 40 kg (about 6 stone 4 lbs) and have an everyday activity score showing they can look after themselves and be up and out of bed for at least half of their normal waking hours.
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.
- I am an adult aged 18 or older.
- I have been diagnosed with AML, MDS, CLL, SLL, or NHL.
- My cancer has returned or has stopped responding to prior treatments.
- I have tried standard therapies or have no further suitable approved options available.
- I weigh at least 40 kg (approximately 6 stone 4 lbs).
- I am able to look after myself and be out of bed for at least half of the day.
What does participation involve?
If you decide to join, your participation will be divided into three main stages. First is a screening period of up to 30 days, where doctors run tests to ensure the trial is safe for you. Next is the treatment stage, where you will receive JNJ-95804306 either alone or combined with standard medicines. During this time, you will have frequent hospital visits for blood tests, heart checks (ECGs), and physical exams to monitor your safety. The final stage is a follow-up period lasting up to 12 months after your last dose to see how you are feeling. In total, the study runs over several years, but your direct involvement will depend on how your cancer responds to the medicine.
Potential risks and benefits
Locations (1)
- The Christie NHS Foundation TrustCity onlyManchester, England
Common questions
What does 'first-in-human' mean?
It means this trial is the very first time this specific medicine is being tested in people after being developed in laboratory research.
Will I have to stop my current cancer treatment?
This trial is designed for people whose standard treatments have already stopped working. In some trial groups, the new drug is given alongside standard medicines.
Will this drug cure my blood cancer?
It is too early to know. The main focus of a Phase 1 study is to find a safe dose and understand side effects, rather than to test how well it cures the disease.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the study at any point, for any reason, and your medical team will continue to look after your health.
How often will I need to visit the hospital?
Visits will be frequent, especially in the first few weeks, so the doctors can run blood tests, check your vital signs, and monitor you closely for side effects.
How to find out more
Ellice Marwood
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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