The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+/CD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Neoantigen tumor vaccine
Ruijin Hospital
Shanghai, China
Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)
Time frame: Day1 to Day 21
Objective remission rate at the end of treatment
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine
Time frame: Up to approximately 2 years
Overall Survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Time frame: Up to approximately 2 years
Reaction of antigen-specific T cells in peripheral blood
personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses
Time frame: Up to 104 weeks
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