Study of Academic Anti-CD19 CAR-T Cell Therapy for Adults With Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the use of academic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory large B-cell lymphoma LBCL. This observational study aims to assess the effectiveness and safety of a CAR-T cell product made using a lentiviral vector encoding the anti-CD19 CAR in a real-world clinical setting. The study is conducted at the NN Alexandrov National Cancer Centre of Belarus and focuses on patients who have already received prior anti-tumor therapy. The academic CAR-T cell therapy studied encodes an anti-CD19 CAR construct with a specific antibody fragment FMC63 linked to several components for activation and safety, including a safety switch marker. This therapy is administered to patients with confirmed CD19 expression in their tumor tissue. The study observes the treatment as it is given in routine practice without altering the approach. Participants are monitored for response 30 days after CAR-T infusion, focusing on the overall response rate. Secondary outcomes include event-free survival and overall survival measured over five years. Patient evaluations include confirming eligibility based on disease status and prior treatment history. The study tracks safety and outcomes over a long-term period up to five years, with participation lasting from treatment through extended follow-up.

Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse/Refractory B-cell Lymphoma