NCT06912529

Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Universität Münster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II study will evaluate the efficacy, safety and tolerability of second-line treatment with axicabtagene ciloleucel in primary mediastinal B-cell lymphoma patients (PMBCL).

Detailed description

Patients who are refractory or relapse after first-line therapy of PMBCL have poor outcomes when treated with standard salvage therapy consisting of high-dose therapy and autologous stem cell transplantation. Recent studies and real-world data on CAR T-cells in patients with early relapsed or refractory aggressive B-cell lymphoma, particularly diffuse large cell B-Cell lymphoma, showed improved event free survival and overall survival with axicabtagene ciloleucel compared with the previous standard of care. These reports suggest comparable efficacy with similar toxicity profiles for CAR T-cells in PMBCL. However, larger studies with CAR T-cells in patients who are refractory to first-line therapy or who relapse after an initial response are urgently needed.

Conditions

• B-cell Lymphoma Refractory
• B-cell Lymphoma Recurrent

Interventions

Type	Name	Description
PROCEDURE	Leukapheresis	Axicabtagene ciloleucel is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure.
DRUG	Bridging Therapy	Bridging therapy refers to treatment used to control a patient's disease or disease related inflammation prior to lymphodepletion.
DRUG	Lymphodepletion	Patients will receive a non-myeloablative lymphodepleting regimen consisting of fludarabine and cyclophosphamide (FC) to induce lymphocyte depletion and create an optimal environment for expansion of axicabtagene ciloleucel in vivo.
GENETIC	Axicabtagene Ciloleucel	Patient will receive the axicabtagene ciloleucel infusion in the hospital followed by daily monitoring in the hospital.

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2025-04-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Germany