Phase I/II Study Evaluating AUTO4 in Patients With TRBC1 Positive T Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    55
  • sponsor
    Autolus Limited
Updated on 26 January 2021
fludarabine
cyclophosphamide
lymphoma
hodgkin's disease
ejection fraction
measurable disease
gilbert's syndrome
neutrophil count
t-cell lymphoma
peripheral t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma

Summary

The purpose of this study is to test the safety and efficacy of AUTO4 a CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma.

Description

The study will consist of 2 phases, a Phase I/dose escalation phase and a Phase II/expansion phase. Patients with relapsed or refractory TRBC1 positive selected T-NHL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis to harvest T cells, the starting material for the manufacture of the autologous CAR-T product AUTO4. Following preconditioning by a chemotherapeutic regimen, the patient will receive AUTO4 intravenously as a single dose following which they will then enter a 24-month follow-up period

Details
Condition Peripheral T-Cell Lymphoma, anaplastic large cell lymphoma, T-Cell Lymphoma, Angioimmunoblastic Lymphadenopathy
Treatment AUTO4
Clinical Study IdentifierNCT03590574
SponsorAutolus Limited
Last Modified on26 January 2021

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