Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This Phase 2 study will establish the safety and efficacy profile of LMY-920.
LMY-920 is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate malignant B cells. BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on non-Hodgkin lymphoma and multiple myeloma. The goal of the Phase 2 LMY-920-004 study is to establish the safety profile of LMY-920 and to determine the objective response rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Single infusion of 4×10\^6 cells/kg of LMY-920 (autologous CAR-T cell therapy expressing the BAFF-ligand.)
To assess the efficacy of LMY-920 in patients with relapsed or refractory B-cell NHL and MM.
Determine the objective response rate per Lugano Revised Response Criteria for Malignant Lymphoma after treatment with LMY-920 in patients with relapsed or refractory NHL, and per International Myeloma Working Group (IMWG) uniform response criteria in patients with relapsed or refractory MM.
Time frame: 24 Months
To assess the safety of LMY-920 in patients with relapsed or refractory B-cell NHL and MM.
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0. All adverse events during study will be collected, categorized, and graded. Attribution of relatedness to the investigational agent will be assigned.
Time frame: 24 months
To determine the complete response rate.
Complete Response Rate
Time frame: 24 Months
To determine the duration of response in patients with NHL and MM.
Duration of Response
Time frame: 24 Months
To determine progression-free survival
Progression-free Survival
Time frame: 24 Months
To determine the overall survival.
Overall survival.
Time frame: 24 Months
To determine incidence of adverse events
Incidence of adverse events.
Time frame: 24 Months
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