Phase 1 Study of Anti-CD22 CAR T Cell Therapy in Adults with Relapsed or Refractory Hairy Cell Leukemia and Variant

What this Trial Is About

Researchers are studying a new treatment called anti-CD22 CAR T-cell therapy for adults with hairy cell leukemia HCL or its variant HCLv who have relapsed, are refractory, or cannot receive standard treatments. This Phase I study aims to evaluate the safety and feasibility of this therapy, which uses genetically modified T cells designed to target cancer cells. The trial is important because some patients with HCL or HCLv respond poorly to existing therapies and have few treatment options. Participants will first undergo leukapheresis to collect their T cells, which will then be modified in the lab to express the anti-CD22 CAR. Before the CAR T-cell infusion, participants receive chemotherapy drugs fludarabine and cyclophosphamide to prepare the body. The modified CAR T cells will be infused on Day 0, and the dose may be increased in a stepwise manner to find the best balance between safety and effectiveness. Some participants may receive a second infusion if needed. This trial includes dose escalation and dose expansion phases. Throughout the study, participants will have careful monitoring including blood tests, imaging scans, neurological evaluations, and questionnaires. They will stay in the hospital for about 14 days after infusion, followed by frequent visits twice a week for one month. Long-term follow-up includes close monitoring for six months and then less frequent visits for at least five years, with additional evaluations continuing for up to 15 years. Researchers will assess safety, antitumor effects, T-cell persistence, and overall survival among other outcomes.

Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant