A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39P, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
• Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
• Aged 18-75 years (inclusive).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
• At least one evaluable tumor lesion according to Lugano 2014 criteria.
∙ Response to prior therapy is consistent with one of the following:
• Primary refractory.
• Relapsed or refractory after 2 or more lines of therapy.
• For LBCL, 3B FL. t-iNHL:
‣ Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
⁃ Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
‣ 7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria