Early Study of Anti-CD19 Gene Injection Treatment for Patients with Relapsed or Resistant B-cell Lymphoma

What this Trial Is About

Researchers are evaluating an Anti-CD19 gene injection for adults with relapsed or refractory B-cell lymphoma. This open-label, single-site study plans to include up to 18 participants to assess the safety and effectiveness of this gene therapy treatment. The study focuses on various aggressive types of B-cell lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma, among others, in patients who have undergone at least two prior standard treatments without lasting remission. Participants will receive an intravenous infusion of the Anti-CD19 gene injection, tested across three dosage groups to explore the best therapeutic dose. The study involves dose escalation to evaluate safety and monitor treatment effects. The trial does not include a placebo group and is not blinded, meaning both researchers and participants know the treatment being given. During the study, participants will be closely monitored for adverse events and the behavior of the gene injection in the body, such as how long it stays and where it moves, up to one year after treatment. Researchers will also measure treatment responses including complete and objective response rates and the duration of response. Participants will undergo assessments like imaging tests to confirm measurable lesions and regular health evaluations to ensure vital organ function. The total follow-up period for outcomes extends to one year post-infusion.

Anti CD19 Gene Therapy for B-cell Lymphoma