On June 16, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported clinical data of AUTO4 (Phase 1/2 LibrA T1 study), a TRBC1-targeting CAR T cell therapy in relapsed/refractory TRBC1-Positive Peripheral T-Cell Lymphoma (PTCL) at the International Conference on Malignant Lymphoma (ICML) being held June 13 to 17, 2023 in Lugano, Switzerland (Press release, Autolus, JUN 16, 2023, View Source [SID1234632754]). PTCL is a rare and heterogeneous form of non-Hodgkin lymphoma.

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The LibrA T1 trial is a single arm, open label, multi-center, Phase 1/2 study evaluating the safety and efficacy of AUTO4, a single dose intravenous CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1-positive selected PTCL. At the cutoff date of April 28, 2023, 19 patients were enrolled into the study and 13 were dosed. Using manufacturing process A, 10 patients were dosed. Using manufacturing process B, 3 additional patients were dosed very recently. Overall, the treatment was well tolerated with no dose limiting toxicities. In Process A, at the highest dose tested (450 x 106 cell dose), 4 out of 4 patients achieved a response with 2 out of 4 remaining in ongoing complete metabolic response (CMR) at 15 and 18-months post-dose, respectively. Presence of CAR T cells in the lymph nodes of patients suggest fast homing of CAR T cells to the tumor site, despite absence in the blood. Efficacy data from Process B was not provided given median follow up is <3 months.

"There are limited options for patients with PTCL, so new treatments for this aggressive malignancy are desperately needed," said Dr. Kate Cwynarski, Chief Investigator, UCLH, London. "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 harbors 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."

"AUTO4, with its unique targeting mechanism, represents an opportunity for advanced programmed T cell therapies that will make a difference in patients who traditionally suffer from severe immunosuppression as a result of current therapeutic options," said Dr. Edgar Braendle, Chief Development Officer of Autolus. "This is a trial with a small number of patients, but with all 4 patients at the highest dose in the study achieving a response and 2 out of the 4 remaining in a complete metabolic response beyond 12 months, AUTO4 shows potential to provide a novel therapy option for PTCL patients."

Oral Presentation

Title: First in Human Study of AUTO4, a TRBC1-Targetting CAR T Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma

Abstract No: 044 – Link to Abstract
Session: Peripheral T-cell Lymphomas
Session Date and Time: Thursday, June 15, 2023, 4.30 – 4.45pm CET

Presenting Author: Dr Kate Cwynarski, Consultant Haematologist University College London Hospitals (UCLH)