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Trial Information
Molecule Overview
BAFF-R Bispecific T-Cell Engager
LY4152199
Phase
1
Active, not recruiting
A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-Cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-Cell Malignanciesa
Related Resources:
Trial Enrollment
BAF_FRontier-1
Key Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Estimated life expectancy of ≥12 weeks as judged by the investigator
  • 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 measurable or assessable disease for respective B-cell malignancy
  • Must have failed or were intolerant to at least 2 prior lines of therapy
  • Phase 1a dose escalation (Cohort A): Must have histologically confirmed relapsed/refractory B-cell malignancy:
    • Eligible malignancies include diffuse large B-cell lymphoma (NOS or transformed from FL) and FL (Grades 1 to 3a)
  • Phase 1a dose optimization (Cohort B1):
    • Must have histologically confirmed relapsed/refractory DLBCL, either de novo or transformed
  • Phase 1a dose optimization (Cohort B2):
    • Must have FL (grades 1 to 3a)
Key Exclusion Criteria
  • All individuals
    • Known or suspected central nervous system (CNS) involvement by systemic lymphoma or leukemia
    • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
    • Any unresolved toxicities from prior therapy 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-modified T-cell (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed
    • Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH)
    • Active second malignancy, unless in remission, with life expectancy greater than 2 years, and with documented sponsor approval are eligible
    • History of or active autoimmune disease
    • Significant cardiovascular disease
    • Active uncontrolled systemic infection or other clinically significant medical conditions
    • Prior treatment with BAFF-R directed therapies (eg, monoclonal antibody, CAR-T, or bispecific antibody)
    • Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention 
a
This clinical trial is being conducted globally.
b
Includes DLBCL not otherwise specified and transformed from FL.
c
Grades 1 to 3a.
d
Administered intravenously.
e
Step-up dosing is required for the first cycle at each dose level.
f
At least 2 dose levels will be evaluated.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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