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

NCT06912529 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-09-04

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • Universität Münster

    lead OTHER

Principal Investigators

  • Georg Lenz, Prof · Universität Münster

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2025-07-25
Completion
2025-07-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912529 on ClinicalTrials.gov