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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BAFF-R T-Cell Engager
LY4152199
Phase
1
Active, not recruiting
A First-in-Human, Phase 1a/1b 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
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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
  • Phase 1a dose escalation (Cohort A): Must have histologically confirmed relapsed/refractory B-cell malignancy:
    • Eligible malignancies include diffuse large B-cell lymphoma (DLBCL) (not otherwise specified [NOS], transformed from follicular lymphoma [FL], high-grade B-cell lymphoma), FL (Grades 1 to 3a), small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and Waldenström macroglobulinemia (WM). Mantle cell lymphoma (MCL), Richter’s transformation (RT), and Burkitt lymphoma may be enrolled, with sponsor approval, into backfill dose level (DL) where dose-limiting toxicity (DLT) has been cleared
  • Phase 1a dose optimization (Cohort B):
    • Must have histologically confirmed relapsed/refractory DLBCL, either de novo or transformed
  • Phase 1b dose expansion (Cohort C): Must have a histologically confirmed diagnosis of relapsed/refractory B-cell malignancies as defined below per specific cohort. Transplant eligibility or ineligibility may be determined by the investigator
    • Cohort C1a: Transplant-ineligible DLBCL (NOS, high-grade B-cell lymphoma, transformed from FL). Burkitt lymphoma is excluded
    • Cohort C1b: Transplant-eligible DLBCL (NOS, high-grade B-cell lymphoma, transformed from FL). Burkitt lymphoma is excluded
    • Cohort C1c: RT
    • Cohort C2: FL (Grades 1 to 3a)
    • Cohort C3: MCL, MZL, WM
    • Cohort C4: Chronic lymphocytic leukemia (CLL)/SLL
    • Cohort C5: B-cell acute lymphoblastic leukemia (B-ALL)
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
NOS, transformed from FL, high-grade B-cell lymphoma.
c
Grades 1a to 3a.
d
MCL, RT, and Burkitt lymphoma may be enrolled into backfill cohorts.
e
Administered intravenously.
f
Administered subcutaneously.
g
Stratification factor: GCB or non-GCB.
h
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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