Study of LCAR-HL30 Cell Therapy for Adults With Relapsed or Refractory Hodgkins Lymphoma and Anaplastic Large Cell Lymphoma

What this Trial Is About

Researchers are evaluating LCAR-HL30, a chimeric antigen receptor CAR-T cell therapy, in adults with relapsed or refractory Hodgkins Lymphoma and Anaplastic Large Cell Lymphoma. This open-label, single-arm, exploratory clinical study aims to assess the safety, tolerability, pharmacokinetics, and anti-tumor effects of LCAR-HL30 in these patients. The trial is sponsored by Ruijin Hospital and includes adults aged 18 to 75 years with confirmed CD30-positive lymphoma. Participants will receive a conditioning premedication regimen of cyclophosphamide and fludarabine before the infusion of LCAR-HL30 cells. The study involves sequential stages screening, pre-treatment with lymphodepleting chemotherapy, treatment with LCAR-HL30 infusion, and follow-up. This phase 1 study focuses on finding the recommended dose and monitoring the therapys behavior in the body. During the study, patients will be closely monitored for treatment-emergent adverse events and pharmacokinetics in blood and bone marrow for up to four years after infusion. Researchers will assess response rates, duration of remission, progression-free survival, overall survival, and the presence of antibodies against LCAR-HL30. Participants will undergo laboratory tests and clinical evaluations throughout the follow-up period to evaluate safety and efficacy outcomes.

A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma