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Friday, 06/11/2021 2:40:53 PM

Friday, June 11, 2021 2:40:53 PM

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As of the data cut-off date of May 17, thirteen patients in Cohort D with R/R IBCL had been enrolled in the trial and product was successfully manufactured for twelve patients, with one patient’s cells ongoing in manufacture. As of the data cut-off date, nine had received AUTO1 infusion. Three were pending infusion (including the patient above) and one patient died prior to lymphodepletion due to a Cov infection. Obe-cel was well tolerated and demonstrated a favourable safety profile, despite high disease burden. All treated patients achieved a complete metabolic response and had robust CAR-T engraftment, expansion, and persistence.

Grade 1 CRS was reported in four patients and Grade 2 CRS in one. No immune effector cell-associated neurotoxicity syndrome of any grade was observed. At a median follow-up of six months (range 4.0-8.1), eight of nine patients were disease free, with one relapse at month six, but was rescued with radiotherapy. One died of a Cov infection at month 5.6 whilst in complete metabolic response.

Also, twenty patients in Cohort A with R/R aALL had received obe-cel. The therapy was well tolerated, with no patients experiencing Grade 3 or higher CRS. Three patients, all of whom had high leukaemia burden (over 50% blasts), experienced Grade 3 ICANS that resolved swiftly with steroids.

Of the twenty patients evaluable for efficacy, seventeen achieved minimum residual disease negative complete response at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival at twelve months and twenty-four months is 50.2% with the median not being reached.

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