Pilot Study of Anbalcabtagene Autoleucel for Adults With Relapsed or Refractory Primary or Secondary CNS Lymphoma

What this Trial Is About

Researchers are evaluating Anbalcabtagene autoleucel Anbal-cel, an investigational CAR-T cell therapy, in patients with relapsed or refractory primary central nervous system lymphoma PCNSL or secondary CNS lymphoma SCNSL, which are aggressive B-cell lymphomas with poor outcomes. This phase 2, open-label pilot study aims to assess the safety, tolerability, pharmacokinetics, and early effectiveness of Anbal-cel in this patient group, addressing the need for new treatments due to limited success of current options. Participants undergo leukapheresis to collect cells for Anbal-cel manufacturing, followed by lymphodepletion chemotherapy with fludarabine and cyclophosphamide before infusion. Anbal-cel is given as a single intravenous infusion at a dose of 2 x 106 CAR-T cells per kilogram, within 30 minutes of thawing. The study includes a safety lead-in phase with initial patients receiving the recommended dose, with ongoing safety assessments before further enrollment. During the study, patients are hospitalized for at least 7 days after receiving Anbal-cel for close monitoring and treatment of any side effects. They will have regular primary evaluations for 12 months, with additional follow-up visits if evaluations end early due to progression or other reasons. A separate 15-year long-term follow-up study will monitor delayed effects and long-term safety. Researchers will measure response rates, survival outcomes, immune responses, and safety over 24 months.

Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma