Study of ATLCAR.CD30.CCR4 Cell Therapy with Chemotherapy for Adults with Relapsed or Refractory CD30 Classical Hodgkin Lymphoma A Phase 1b2 Trial to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are studying a new treatment for Hodgkins Lymphoma, a cancer that remains fatal for more than 15% of patients despite existing therapies. This phase IbII trial focuses on ATLCAR.CD30.CCR4 cells, which target the CD30 antigen commonly expressed on Hodgkins Lymphoma cells. The study aims to find the safest dose and evaluate how well this therapy works to delay disease progression. Participants will be enrolled into one of three dose levels using a 33 design. Eligible subjects may have their cells collected to create the ATLCAR.CD30.CCR4 cells. While the cells are being prepared, patients can receive standard bridging therapy as needed. Then, participants will undergo chemotherapy with bendamustine and fludarabine to reduce immune cells before receiving the ATLCAR.CD30.CCR4 cell infusion 2 to 14 days later. During the study, participants will be closely monitored for side effects and response to treatment, including specific assessments for adverse events and immune-related toxicities up to 6 weeks after infusion. The main measurement in phase II is progression-free survival over 6 months. Patients will be followed for up to 15 years to monitor long-term effects related to the gene transfer therapy. The trial is conducted as an open-label, single-group study at a single center.

ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells