Trials / Terminated
TerminatedNCT03590574
Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma
A Single Arm, Open Label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO4, a CAR T-cell Treatment Targeting TRBC1, in Patients With Relapsed or Refractory TRBC1 Positive Selected T Cell Non-Hodgkin Lymphoma
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Autolus Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and efficacy of AUTO4 a chimeric antigen receptor (CAR) T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma (NHL).
Detailed 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
Conditions
- T Cell Non-Hodgkin Lymphoma
- Peripheral T-Cell Lymphoma, Not Otherwise Specified
- Angioimmunoblastic T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AUTO4 | AUTO4 (Ritux-QBEND/10-Ritux-CD8 sort-suicide gene generated as a marker/suicide gene for T cells \[RQR8\]/anti-T cell receptor beta constant \[aTRBC\]1 CAR T cells). Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with doses from 25 to 900 x 10\^6 RQR8/anti-TRBC1 CAR T cells in Phase I. Following dose determination patients will be treated with the selected doses of RQR8/aTRBC1 CAR T cells (AUTO4) in Phase II. |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2024-12-12
- Completion
- 2024-12-12
- First posted
- 2018-07-18
- Last updated
- 2026-03-16
- Results posted
- 2026-03-16
Locations
5 sites across 2 countries: Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03590574. Inclusion in this directory is not an endorsement.