Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, 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 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
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. The goal of LMY-920-001 phase 1 study is to find recommended phase 2 dose of LMY-920 for treatment of patients with relapsed or refractory non-Hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Autologous CAR-T cell therapy expressing the BAFF-ligand.
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
NOT_YET_RECRUITINGTaussig Cancer Institute | Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGTo determine recommended phase II dose of human LMY-920.
Maximum tolerated dose.
Time frame: 24 months
To establish toxicity profile for the infusion of LMY-920.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. 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 objective response rate .
Response rate.
Time frame: 24 months
To determine the complete response rate.
Response rate.
Time frame: 24 months
To determine the duration of response.
Duration of response.
Time frame: 24 months
To determine the 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
To determine incidence of anti- LMY-920 antibodies.
Incidence of anti- LMY-920 antibodies.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.