Unum plans additional cohort after cytokine release syndrome, neurotoxicity reports in Phase I lymphoma cell therapy study – source

15 Dec 2017

Cytokine release syndrome (CRS) and neurotoxicity incidents have prompted Unum Therapeutics to evaluate a new dosing cohort in its Phase I study of cell therapy ACTR087 in relapsed/refractory non-Hodgkin’s lymphoma, said a source briefed on the situation.
Speaking on the sidelines of the recently concluded ASH meeting, the source said that in the trial (NCT02776813), which combines ACTR087 with Roche’s (VTX:ROG) Rituxan (rituximab), Unum will experiment with giving a flat dose of the cells and a 100mg/m2 dose of Rituxan in an attempt to cut down the toxicity, which was seen in the second dosing cohort. The company has not specified what the cell dose will be, the source added.
If the cells are able to persist with the 100mg/m2 Rituxan dose, then it will be used for the rest of the trial, the source said. Under the current protocol, patients receive 375mg/m2 Rituxan in the first and second cohorts.

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