Not yet recruitingPHASE1INTERVENTIONAL

A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )

This research study is looking at a new medicine called LY4152199 for individuals diagnosed with specific types of B-cell lymphoma, including Non-Hodgkin lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma, as well as some other related conditions. Participants in the study will have already received other treatments that weren't fully successful. The main goals are to figure out the safest and most effective dose of LY4152199, and to understand any side effects it might have. This is a Phase 1 study, which means it's one of the first times this drug is being tested in humans. Participants will receive the drug through a drip into their vein and may have the option to continue receiving the treatment until the study concludes.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

215

Start

01 Jun 2026

Estimated completion

01 Sep 2029

Lymphoma, Non-Hodgkin B-cell Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, B-cell Marginal Zone Waldenstrom Macroglobulinemia Lymphoma, Mantle Cell

What is this study about?

This research study, called BAF_FRontier-1, is exploring a new treatment called LY4152199 for people who have specific types of B-cell lymphoma. These are cancers that affect a certain type of white blood cell called B-cells. The study is particularly for people whose cancer has either come back or hasn't responded well to earlier treatments.

The main aims of this study are to discover the most effective dose of LY4152199, understand its safety, and see how well it works. Because this is a 'Phase 1' study, it means it's one of the first times this drug is being tested in people. The researchers carefully watch participants to see how their bodies react to the new medicine. They want to make sure it's as helpful and safe as possible.

Participants will receive the study drug, LY4152199, through a drip directly into their vein. This study offers participants the chance to continue receiving the new treatment for a longer period if they choose, right up until the end of the study. This approach helps researchers gather as much information as possible about the drug's long-term effects.

Key takeaways

This study is for a new drug called LY4152199 for specific types of B-cell lymphoma.
It's for people whose lymphoma has returned or hasn't responded to previous treatments.
The main goals are to find the best dose and check for safety and effectiveness.
You will receive the drug through an IV drip.
This is a 'Phase 1' study, meaning it's an early stage of drug testing in humans.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To be considered for this study, you need to have certain types of B-cell lymphoma, such as follicular lymphoma or diffuse large B-cell lymphoma, that have either come back or not responded to previous treatments. Your doctor will also check that you are generally well enough to take part, meaning you can do most of your daily activities without much trouble, and they believe you have a life expectancy of at least 12 weeks.

It's important that your cancer can be measured by doctors, either through a visible lump, involvement in your bone marrow, or specific blood tests if you have Waldenstrom macroglobulinemia. You also need to be able to come to all the required hospital appointments and tests.

There are also some reasons why you wouldn't be able to join. For instance, if you have too many cancer cells in your blood, if the cancer has spread to your brain or spinal cord, or if you have specific brain conditions like a history of stroke or epilepsy. Any serious side effects from previous treatments also need to have mostly cleared up before you can start this study, except for hair loss.

Quick self-check

Do you have a diagnosis of follicular lymphoma or diffuse large B-cell lymphoma?
Has your lymphoma either returned or not responded to previous treatments?
Are you generally well and able to carry out most daily activities?
Do doctors consider your cancer to be measurable (e.g., a visible lump or specific blood markers)?
Do you have good organ function (e.g., healthy kidneys and liver)?
Have any serious side effects from previous treatments mostly cleared up (except for hair loss)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the new drug, LY4152199, directly into your vein (like a drip). The research team will carefully monitor you throughout the study with regular visits to the hospital, which will involve various assessments, blood tests, and check-ups. These visits help the doctors understand how the drug is working and if you are having any side effects. You'll need to be available for these appointments. You may be able to continue receiving the treatment until the study concludes, depending on how you respond. The total duration of your participation will depend on the study's design and your individual response.

Potential risks and benefits

Participating in a study like this means you might be among the first to try a new treatment that could potentially help your condition, especially if other treatments haven't worked. However, there are also potential risks as LY4152199 is still being tested, and not all side effects are known or fully understood yet. You might experience side effects, some of which could be serious. The research team will explain all known risks to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

City of Hope
Duarte, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, United States
Colorado Blood Cancer Institute
Denver, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, United States
The University of Chicago Medical Center (UCMC)
Chicago, United States
University of Iowa
Iowa City, United States
University of Kansas Cancer Center
Kansas City, United States
Massachusetts General Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, United States
Mayo Clinic - Rochester
Rochester, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States

+38 more sites — see the official record for the full list.

Common questions

What is LY4152199?

LY4152199 is a new investigational drug being tested to treat certain types of B-cell lymphoma.

What does 'B-cell malignancies' mean?

B-cell malignancies refer to cancers that start in B-cells, which are a type of white blood cell important for your immune system. This includes various forms of lymphoma.

What is a Phase 1 study?

A Phase 1 study is one of the first times a new drug is tested in people. The main goals are to find a safe dose range and to identify any common side effects.

How will I receive the treatment?

The treatment, LY4152199, will be given to you through a drip into your vein (intravenously).

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point without it affecting your future medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

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