LY4152199 for B-Cell Cancers

(BAF-FRontier-1 Trial)

Not yet recruiting at 47 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4152199 for certain types of B-cell cancers, such as lymphoma and leukemia, particularly in individuals whose previous treatments were ineffective. The trial consists of two parts: determining the optimal dose and evaluating its effectiveness. It seeks participants with B-cell cancers that have recurred or not responded to other treatments. Participants should be able to manage regular hospital visits and adhere to the treatment plan. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.

Is there any evidence suggesting that LY4152199 is likely to be safe for humans?

Research has shown that LY4152199 is being tested for safety in people with B-cell cancers, such as lymphoma and leukemia. This is a Phase 1 trial, which aims to assess the drug's safety and determine the optimal dose.

Phase 1 trials mark the first time new treatments are tested in humans. Before this phase, LY4152199 was likely tested only in labs or on animals. Researchers focus on identifying any side effects and evaluating how well participants tolerate the treatment. Although specific data from earlier studies is not available, reaching this phase suggests LY4152199 might be safe enough for human testing. However, it remains crucial to closely monitor participants for any adverse effects.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for B-cell cancers, which often include chemotherapy or targeted therapies like Rituximab, LY4152199 introduces a novel approach. This treatment is unique because it can be administered both intravenously (IV) and subcutaneously (SC), offering flexibility in delivery methods. Researchers are excited about LY4152199 as it explores dose optimization and escalation, potentially enhancing effectiveness with fewer side effects. This innovation could lead to more personalized and manageable treatment options for patients with B-cell cancers.

What evidence suggests that LY4152199 might be an effective treatment for B-cell cancers?

This trial will evaluate LY4152199 for its potential to combat B-cell cancers by interacting with the body's immune cells. Research has shown that LY4152199 is designed to connect with two types of cells: one on T cells and another on B cells, aiding in the destruction of cancerous B cells. Although human studies have provided limited information, early results suggest that LY4152199 could be effective against B-cell lymphoma and leukemia. Further research is necessary to confirm these effects in people. Participants in this trial will receive LY4152199 in various dosing regimens to assess its safety and effectiveness.12346

Who Is on the Research Team?

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people who have had treatment for B-cell cancers like lymphoma or leukemia but need more options. They should be able to visit the clinic regularly and have a life expectancy of at least 12 weeks. Participants must show signs of their disease, such as certain levels of proteins in the blood or cancer cells in bone marrow.

Inclusion Criteria

My doctor believes I have 12 weeks or more to live.
I am part of the Phase 1a dose optimization study.
I can attend all treatment sessions, tests, and clinic visits required by the trial.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Escalating doses of LY4152199 administered intravenously (IV) or subcutaneously (SC) to determine the best dose

Variable duration

Dose Optimization

Two or more doses of LY4152199 evaluated during dose escalation administered subcutaneously (SC)

Variable duration

Dose Expansion

LY4152199 administered subcutaneously (SC) to assess efficacy at the optimized dose

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • LY4152199
Trial Overview LY4152199 is being tested both through IV (intravenous) and SC (subcutaneous) injections. The study has two parts: first, finding the best dose; second, testing how effective that dose is against various types of B-cell cancers and leukemia.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Phase 1B: Dose Expansion (Cohort C)Experimental Treatment1 Intervention
Group II: Phase 1A: Dose Optimization (Cohort B)Experimental Treatment1 Intervention
Group III: Phase 1A: Dose Escalation (Cohort A)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

NCT07101328 | A Study of LY4152199 in Participants With ...The purpose of this study is to measure the safety and efficacy of LY4152199 in participants with previously treated B-cell lymphoma and leukemia.
LY4152199, a First-in-Class BAFF-RxCD3 Bispecific ...In co-culture assays with T cells and BAFF-R-expressing malignant B cells, LY4152199 engaged both CD3 and BAFF-R to induce concentration- ...
LY4152199 for B-cell Malignancies After Prior TreatmentThis study is focused on evaluating a new medication called LY4152199 for adults who have previously been treated for B-cell lymphoma or leukemia.
A Study of LY4152199 in Participants With Previously ...The purpose of this study is to measure the safety and efficacy of LY4152199 in participants with previously treated B-cell lymphoma and leukemia.
LY4152199 for B-Cell Cancers (BAF-FRontier-1 Trial)The purpose of this study is to measure the safety and efficacy of LY4152199 in participants with previously treated B-cell lymphoma and ...
2785 LY4152199, a First-in-Class BAFF-RxCD3 Bispecific ...In co-culture assays with T cells and BAFF-R-expressing malignant B cells, LY4152199 engaged both CD3 and BAFF-R to induce concentration-dependent T-cell ...
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