Phase 1 Study of RD13-02 CAR-T Cell Therapy for Patients Aged 3 to 70 With Relapsed or Refractory CD7-Positive Natural KillerT Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and behavior of CD7 Chimeric Antigen Receptor-T CAR-T therapy in patients who have CD7-positive relapsed or refractory natural killerT cell lymphoma. This phase I study is conducted at a single center and aims primarily to assess safety and pharmacokinetics of the CAR-T cells in this patient group. The trial focuses on individuals aged 3 to 70 years with this specific lymphoma type that is difficult to treat with standard options. Participants receive an intravenous infusion of RD13-02 cells designed to target CD7. This study has a single treatment arm where all patients get the CAR-T cell infusion. The trial monitors the treatment effects and safety over time, with the main outcome measured four weeks after infusion. Secondary outcomes include tracking remission duration, event-free survival, and overall survival up to one year following the treatment. During the study, participants will be closely evaluated for treatment response and any side effects. Assessments include blood tests, heart function checks, oxygen levels, and performance status evaluations. Researchers also monitor survival and remission status for up to one year post-infusion. Participants or their guardians must provide informed consent, and ongoing follow-up ensures safety and gathers data on how well the CAR-T cells work in this lymphoma.

RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies