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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

This research study is for adults in the UK who have non-Hodgkin lymphoma that has returned or hasn't responded to previous treatments. We are testing a new investigational drug called BMS-986458, which is designed to target specific cells. The study aims to understand if BMS-986458 is safe, what dose can be tolerated, and how the body handles the drug when given alone. We also want to see if it shows any signs of helping to control the lymphoma. Additionally, the study will look at BMS-986458 in combination with existing anti-lymphoma treatments like Rituximab, Glofitamab/Obinutuzumab, and Mosunetuzumab, to see if combining them could be more effective. This is an early-stage study (Phase 1 and 2), meaning it's primarily focused on safety and initial effectiveness.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Bristol-Myers Squibb
Enrolment target
308
Start
29 Dec 2023
Estimated completion
28 Oct 2028

What is this study about?

This study is investigating a new treatment called BMS-986458 for adults with non-Hodgkin lymphoma. This is a type of cancer that starts in white blood cells called lymphocytes. The study is particularly for people whose lymphoma has either come back after previous treatments (relapsed) or hasn't responded to those treatments (refractory).

The main goals of this research are to understand how safe the new drug, BMS-986458, is and to find a dose that people can tolerate well. We will also be looking at how the body processes the medication and if it shows any early signs of helping to control the lymphoma. The study will test BMS-986458 on its own, and also in combination with some other anti-lymphoma drugs that are already used, such as Rituximab.

By taking part, you would be helping us learn more about this potential new medicine. This is an early-stage study, which means it’s one of the first times this drug is being tested in humans in this way. The information we gather will help doctors decide if it could be a useful treatment option in the future for people with non-Hodgkin lymphoma.

Key takeaways

  • This study is for adults with non-Hodgkin lymphoma that has returned or is not responding to treatment.
  • It tests a new drug, BMS-986458, both alone and with other established anti-lymphoma medications.
  • The main goals are to check the new drug's safety, how it's handled by the body, and if it shows early signs of working.
  • Participation involves screening, receiving treatment, and regular hospital visits for monitoring.
  • Being part of a trial means access to new treatments, but also potential unknown side effects.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be 18 years or older and have a type of non-Hodgkin lymphoma that has either come back or not responded to at least two previous treatments. Your lymphoma must also be measurable, meaning doctors can clearly see and track it with scans. Women taking part in the study must agree to use effective contraception to prevent pregnancy.

There are certain reasons why you might not be able to join. For example, if your general health and how well you can go about your daily activities are not at a certain level, or if you've had specific other treatments recently, such as particular types of stem cell transplants, radiotherapy, or CAR-T cell therapy within a certain timeframe before the study starts. You also wouldn't be able to join if you have certain other medical conditions or an inability to follow all the study's rules and restrictions, for your safety.

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.

  1. Are you 18 years old or older?
  2. Do you have non-Hodgkin lymphoma that has come back or not responded to at least two previous treatments?
  3. Can your lymphoma be clearly measured by medical scans?
  4. Are you able to regularly attend hospital appointments for monitoring?
  5. If you are a woman, are you willing to use effective birth control during the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a screening process to see if you meet all the requirements. This would involve various tests and assessments. Once enrolled, you would receive the study treatment, which could be BMS-986458 on its own or in combination with other anti-lymphoma drugs (Rituximab, Glofitamab/Obinutuzumab, or Mosunetuzumab). You would have regular hospital visits for medical checks, blood tests, and scans to monitor your health and how the treatment is affecting your lymphoma. The specific schedule and total duration of your participation would depend on which part of the study you are in and your individual response to treatment. You would be fully informed about all visit schedules and commitments before making a decision.

Potential risks and benefits

Taking part in an early-stage clinical trial means you might gain access to a new, experimental treatment that isn't yet widely available. While there's no guarantee the treatment will help your lymphoma, your participation contributes valuable information that could benefit future patients. However, new treatments can also have unknown side effects or might not be more effective than standard care. You might experience side effects from the study drug or combination treatments, some of which could be serious. All potential risks and benefits will be fully explained by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (65)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic in Arizona - Phoenix
    Verified postcode
    Phoenix, United States· Recruiting
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States· Recruiting
  • Local Institution - 0068
    Verified postcode
    Jacksonville, United States· Not yet recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • Local Institution - 0014
    Verified postcode
    Fairway, United States· Not yet recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Mayo Clinic in Rochester, Minnesota
    Verified postcode
    Rochester, United States· Recruiting
  • Local Institution - 0124
    Verified postcode
    Omaha, United States· Not yet recruiting
  • Local Institution - 0047
    Verified postcode
    Lake Success, United States· Completed
  • Local Institution - 0037
    Verified postcode
    New York, United States· Not yet recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Local Institution - 0040
    Verified postcode
    Pittsburgh, United States· Not yet recruiting

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.

What does 'relapsed/refractory' mean?

It means the lymphoma has either come back after previous treatments (relapsed) or hasn't responded to those treatments (refractory).

What is BMS-986458?

BMS-986458 is a new investigational drug being tested in this study. It aims to target specific cells involved in lymphoma.

Will I receive the new drug alone or with others?

The study will test BMS-986458 on its own and in combination with other existing anti-lymphoma drugs like Rituximab. Which you receive will depend on the study design.

What 'phase' is this study?

This is a Phase 1 and Phase 2 study, which means it's an early-stage trial primarily focused on understanding the drug's safety and early signs of effectiveness.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Assess BMS-986458 Alone and in Combination With A…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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