dm+d

Unassigned

New Medicines

Relapsed or refractory TRBC1 positive T-cell lymphoma including peripheral T-cell lymphoma, T cell non-Hodgkin lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma

Information

New molecular entity
Autolus
Autolus

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
None

Category

A chimeric antigen receptor (CAR) T-cell therapy targeting TRBC1 (T cell receptor beta constant 1)
All T-cell lymphomas are a type of non-Hodgkin lymphoma [1]. Crude annual rate of T-cell lymphomas diagnoses is 1.08 per 100,000 people. This compares with a rate of 19.21 per 100,000 people for B-cell lymphomas (which can be NHL or Hodgkin type lymphomas) [2].
Relapsed or refractory TRBC1 positive T-cell lymphoma including peripheral T-cell lymphoma, T cell non-Hodgkin lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma
Intravenous

Trial or other data

Nov 20Autolus is expecting PI interim data for AUTO4 in T cell lymphoma in 2021 [6].
Oct 20PI/II LibrA T1 trial is recruiting In Spain and UK (Queen Elizabeth University Hospital in Glasgow, University College London Hospitals, Manchester Royal Infirmary Hospital, Freeman Hospital in Newcastle upon Tyne); collection of primary outcome data now expected Jun 22 [5].
Dec 19NCT03590574 - UK sites UCL, Manchester, Newcastle [4]
Jan 19PI/II LibrA T1 trial is recruiting [3].
Jul 18PI/II LibrA T1 trial to evaluate the safety and efficacy of AUTO-4 in patients with relapsed or refractory TRBC1 positive T-cell lymphoma including peripheral T-cell lymphoma, T cell non-Hodgkin lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma starts (AUTO-TL1; NCT03590574). The two part trial consists of a PI dose escalation part followed by a PII expansion part, and is expected to enrol approximately 55 patients in the UK. Patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR-T product AUTO4 which is a TRBC1 targeting CAR T cell product. Following pre-conditioning 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. Primary outcome of the PII phase is objective response rate post AUTO4 infusion; collection of these data is due to complete Jul 21 [3].