An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Trial Parameters
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 2. Voluntarily willing to participate in the study and sign the written informed consent form 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive 4. 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) 5. At least one measurable lesion by CT or PET per Lugano criteria 6. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1 7. Adequate organ functions 8. Adequate venous access for apheresis 9. Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion 10. 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 Exclusi