An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
• Age ≥18
• Voluntarily willing to participate in the study and sign the written informed consent form
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
• Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT)
• At least one measurable lesion by CT or PET per Lugano criteria
• Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
• Adequate organ functions
• Adequate venous access for apheresis
• Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion
⁃ Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion