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

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Lilly

Status and phase

Begins enrollment in 2 months
Phase 1

Conditions

Lymphoma, Follicular
B-cell Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin

Treatments

Drug: LY4152199 - IV

Study type

Interventional

Funder types

Industry

Identifiers

NCT07101328
27701
J6N-MC-JUCA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

215 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

215 participants in 3 patient groups

Phase 1: Dose Escalation (Cohort A DLBCL and FL)
Experimental group
Description:
Escalating doses of LY4152199 administered intravenously (IV)
Treatment:
Drug: LY4152199 - IV
Phase 1: Dose Optimization (Cohort B1 DLBCL)
Experimental group
Description:
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV
Treatment:
Drug: LY4152199 - IV
Phase 1: Dose Optimization (Cohort B2 FL)
Experimental group
Description:
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV
Treatment:
Drug: LY4152199 - IV

Trial contacts and locations

50

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Central trial contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Physicians interested in becoming principal investigators please contact

Data sourced from clinicaltrials.gov

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