Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT07101328

Not yet recruiting

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

Interventional

Phase 1

Dana-Farber Cancer Institute

Sponsor: Eli Lilly and Company

Last Updated: March 20, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell lymphoma.

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

June 21, 2026

Last Updated by Sponsor

March 20, 2026

Estimated Completion

April 1, 2027

Contact Study

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

Email:LillyTrials@Lilly.com

Phone:1-317-615-4559

Name:Physicians interested in becoming principal investigators please contact

Email:clinical_inquiry_hub@lilly.com

Eligibility

Inclusion Criteria

* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.

* Participants with select tumor types must have measurable or assessable disease as defined below:

* Must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.

* Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.

* Must have adequate organ function.

* Must have failed or were intolerant to at least 2 prior lines of therapy appropriate for available treatment for the specific B-cell malignancy

Exclusion Criteria

All Participants

* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.

* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.

* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.

* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.

* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).

* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.

* History of autoimmune disease

* Significant cardiovascular disease

* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process

* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).

* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).

* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody). This exclusion criterion does not apply to participants seeking retreatment.

* Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.

* Known hypersensitivity to any component or excipient of LY4152199.

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Design Details

AllocationRandomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll215

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Escalating doses of LY4152199 administered intravenously (IV)

Interventions:

LY4152199 - IV

Outcome Measures

Primary Outcome Measures

Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199Approximately 35 days

Secondary Outcome Measures

Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199Baseline up to approximately 91 weeks

Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199Baseline up to approximately 91 weeks

Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR)Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

Assessed by the Investigator per disease-specific response criteria as appropriate or death due to any cause, whichever occurs first

Phase 1 - Duration of Response (DOR)Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

Time between the date of first documented response (CR or PR) to the date of first disease progression or death due to any cause, whichever occurs first

Phase 1- Time to Response (TTR)Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (CR or PR)

Phase 1 - Progression Free Survival (PFS)Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first

Phase 1- Disease Control Rate (DCR)Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy

Percentage of efficacy-evaluable participants who achieved a BOR of CR, PR, or stable disease