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Trial NCT07101328

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

Phase
Phase 1
Sponsor
Eli Lilly and Company
Conditions
Lymphoma, Non-Hodgkin; B-cell Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-cell Marginal Zone; Waldenstrom Macroglobulinemia; Lymphoma, Mantle Cell
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Performance status * 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: * Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement. * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (>)2 times (×) upper limit of normal (ULN) based on local laboratory testing. * 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. Phase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy. Phase 1 Dose Optimization (Cohort B) Participants - Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL). Exclusion Criteria: All Participants * Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL). * Known or suspected central nervous system (CNS) involvement by systemic lymphoma.Brain metastases * 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.Prior malignancy * History of autoimmune disease * Significant cardiovascular diseaseCardiac * 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). * Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.Pregnancy * Known hypersensitivity to any component or excipient of LY4152199.

Restrictions found (5)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County
  • Dana-Farber Cancer Institute · Boston, Suffolk County