A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with diffuse large B-cell lymphoma.
• Patients or their legal guardians voluntarily participate in the study and provide written informed consent.
• Aged 18 to 80 years (inclusive), male or female.
• ECOG performance status score of ≤ 1.
• Life expectancy \> 3 months.
• KPS score ≥ 70.
• Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.
• CD19 positivity confirmed by flow cytometry and/or histopathology.
• According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \[5-PS\] ≥ 4).
• Adequate organ function.
⁃ Female patients of childbearing potential must have a negative urine/blood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.