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RecruitingPHASE1INTERVENTIONAL

TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

This research study is looking at a new treatment called TLN-121 for adults living with specific types of non-Hodgkin lymphoma. This includes cases where the lymphoma has returned after previous treatments or hasn't responded to them. The main goals are to understand how safe the treatment is, how much of the medicine stays in the body over time, and if it shows early signs of shrinking the lymphoma. The study may test TLN-121 on its own or together with other anti-lymphoma medicines. It's a Phase 1 study, meaning it’s among the first times this treatment is being tested in humans, focusing mainly on safety.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Treeline Biosciences, Inc.
Enrolment target
180
Start
23 Jun 2025
Estimated completion
01 Nov 2030

What is this study about?

This study is about exploring a new medicine named TLN-121. It's designed for people who have certain kinds of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of your body's immune system. Sometimes, after initial treatments, the lymphoma can come back (relapse) or it might not respond to the treatments given (refractory). This study aims to find out if TLN-121 could be a helpful new option for these situations.

The main things doctors want to learn from this study are how safe TLN-121 is for people to take, how it moves through and is processed by the body (this is called pharmacokinetics), and if it shows any early signs of reducing the lymphoma. They might give TLN-121 by itself, or they might combine it with other medicines that are already used to treat lymphoma. This helps them understand the best way to use the new treatment.

Because this is a 'Phase 1' study, it means it's one of the first times this new medicine is being given to people. Therefore, the main focus at this stage is very much on safety and understanding how the body reacts to it. The information gathered will be very important for deciding if TLN-121 can be studied further in larger groups of people. It's a step towards finding new ways to help those with non-Hodgkin lymphoma.

Key takeaways

  • This study evaluates a new treatment, TLN-121, for non-Hodgkin lymphoma.
  • It's for lymphoma that has come back or hasn't responded to previous treatments.
  • The main goals are to check safety, how the body handles the medicine, and early signs of effectiveness.
  • It's a 'Phase 1' study, focusing primarily on safety for this new medicine.
  • You must be over 18 and meet specific health and treatment history criteria.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a specific type of non-Hodgkin lymphoma that has either come back or hasn't responded after previous treatments. The doctors will also check if your lymphoma can be measured, meaning they can see it and track its size. Your general health and how well you can go about your daily activities will also be reviewed to make sure you're well enough to take part. For example, your daily energy and activity levels will be assessed.

There are also some reasons why you might not be able to join the study. For instance, if your lymphoma has spread to your brain or spinal cord, you likely won't be able to participate. Also, if you've had certain other treatments recently, like a stem cell transplant or a special type of cell therapy (CAR T-cell therapy), you would need to wait a certain amount of time before joining. If you've had a big surgery or a serious medical condition that isn't under control, this might also mean you can't take part. These checks are to make sure the study is as safe as possible for everyone involved.

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 or older?
  2. Do you have a types of non-Hodgkin lymphoma that has returned or not responded to past treatments?
  3. Is your lymphoma measurable by doctors?
  4. Do you feel well enough to carry out most of your daily activities?
  5. Have you had recent stem cell transplants, CAR T-cell therapy, or major surgery?
  6. Do you currently have lymphoma in your brain or spinal cord?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for assessments. During these visits, doctors will check your overall health, ask about any symptoms you might have, and take blood samples to see how you're reacting to the medicine and how much of it is in your body. You'll receive the study medicine, TLN-121, possibly along with other treatments, as directed by the study doctors. Imaging scans, like CT scans, will be done regularly to see if your lymphoma is shrinking or changing. The total duration of your participation could vary, as you would continue treatment as long as it's helping you and you're not having side effects that are too difficult to manage, followed by a period where doctors continue to check in with you after treatment ends.

Potential risks and benefits

Being part of any research study has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment, TLN-121, which could potentially help your lymphoma when other treatments haven't worked or have stopped working. However, as with all new medicines, there's a chance you might experience side effects, some of which could be serious or unknown at this stage. The study team will monitor you closely for any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

  • Stanford Medicine Cancer Center
    Verified postcode
    Palo Alto, United States· Recruiting
  • The START Center for Cancer Care - Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • SCRI Oncology Partners
    Verified postcode
    Nashville, United States· Recruiting
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Macquarie University Hospital
    Verified postcode
    Macquarie Park, Australia· Recruiting
  • Princess Alexandra Hospital
    Verified postcode
    Woolloongabba, Australia· Recruiting
  • Cabrini Health
    Verified postcode
    Malvern, Australia· Recruiting
  • Peter MacCallum Cancer Centre
    Verified postcode
    Melbourne, Australia· Recruiting
  • Linear Clinical Research
    Verified postcode
    Perth, Australia· Recruiting
  • BC Cancer - Vancouver
    Verified postcode
    Vancouver, Canada· 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 your body's immune system.

What does 'relapsed or refractory' mean?

'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer didn't respond to previous treatments.

What is a Phase 1 study?

A Phase 1 study is one of the first times a new medicine is tested in people. The main goals are to check its safety and find the right dose.

Will I get TLN-121?

If you're eligible and decide to join, you would receive TLN-121, either on its own or in combination with other anti-lymphoma therapies.

What is the study contact for?

The contacts can provide more detailed information about the study, answer your questions, and help you understand if it might be right for you.

How to find out more

Treeline Clinical Operations

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 "TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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