Autolus Therapeutics has reported positive results from the Phase I/II LibrA T1 study of AUTO4, a TRBC1-targeting CAR T cell therapy, for the treatment of relapsed/refractory TRBC1-positive peripheral T-cell lymphoma (PTCL).
The multi-centre, open-label, single-arm study has evaluated the efficacy and safety of a single dose of AUTO4 administered intravenously to patients with TRBC1-positive selected PTCL, a rare and heterogeneous form of non-Hodgkin lymphoma.
Out of 19 patients enrolled, ten were dosed using manufacturing process A and three using manufacturing process B.
Four out of four patients who were administered with the highest dose tested (450 x 106 cell dose) achieved a response using the original manufacturing process A.
Complete metabolic responses in two out of four patients are being observed at 15 and 18 months post-dosing, respectively.
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Median follow-up of less than three months has been determined for the patients treated using Process B and efficacy data is not provided.
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By GlobalDataNo dose-limiting toxicities were reported in the study.
UCLH, London chief investigator Dr Kate Cwynarski said: “The LibrA T1 study of AUTO4 is a novel approach using a CAR T cell designed to selectively target and eliminate T cells that include the malignant clone, which harbours the TRBC1 receptor while preserving the T cell compartment with the TRBC2 receptor which helps to maintain immune-competence.
“AUTO4 is well tolerated and the data to date in this early phase study are very promising.”
Autolus is also engaged in developing product candidates for treating solid tumours and haematological malignancies.
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