GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma: an Open-Label, Randomized, Phase I/II Study
Targeted therapy against the CD30 molecule has achieved some progress in CD30-positive Hodgkin lymphoma, but its efficacy remains unsatisfactory. Previous studies have demonstrated that N-glycan modifications in the extracellular domain of target proteins can disrupt immune synapse formation with CAR-T cells. Our preliminary research has shown that ablation of N-glycans on CD30 enhances the anti-tumor effect of CD30-targeted therapy.It is hypothesized that Eliglustat, by inhibiting GSL synthesis,may potentiate the anti-tumor effect. Consequently,we designed and initiated a single-center, open-label phase I/II clinical study to evaluate the efficacy and feasibility of Eliglustat combined with CD30 targeted immunotherapy in patients with CD30-positive lymphoma. The primary endpoint of this study is the safety and efficacy of Eliglustat combined with CD30 targeted therapies.
• 18 to 75 years of age.
• ECOG performance of less than 2.
• Subjects must have histological confirmation CD30+ lymphoma.
• Patients must have at least one line of antitumor therapy
• Life expectancy of at least 3 months.
• Subjects with lymphoma must have at least one measureable lesion \>1cm as defined by lymphoma response criteria.
• Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity.
• Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
• Subjects must have adequate marrow, live, renal and heart functions.