FDA Places Partial Clinical Hold on Unum Therapeutics Phase I Trial for non-Hodgkin Lymphoma Due to Safety Concern

Mar 13, 2020 | Challenging Pharma, News, Pharma Watch

FDA Places Partial Clinical Hold on Unum Therapeutics Phase I Trial for non-Hodgkin Lymphoma Due to Safety Concern

In a filing with the U.S. Securities and Exchange Commission, Unum Therapeutics disclosed a verbal notification was received from the U.S. Food & Drug Administration (FDA) that it had placed a partial clinical hold on the Phase 1 trial (ATTCK-20-03) of Unum’s ACTR707 in combination with rituximab in patients with CD20+ B cell non-Hodgkin lymphoma (r/r NHL). The partial clinical hold was initiated following the submission of a safety report by Unum to the FDA regarding one patient in the trial who experienced a Grade 3 serious adverse event that is being evaluated as a possible new malignancy and is considered to be possibly related to ACTR707. Unum plans to work closely with the study site and the FDA to further review this event. Patients who previously received ACTR707 can continue to receive rituximab infusions on study. 

Earlier this month, Unum announced a new strategic effort prioritizing and allocating resources towards the advancement of its preclinical program, BOXR1030, for the treatment of advanced solid tumor cancers. As part of the implementation of the new strategic effort, Unum announced that it is concluding its clinical trials of ACTR707, including the Phase 1 trial (ATTCK-20-03) in combination with rituximab in r/r NHL and the Phase 1 trial (ATTCK-34-01) in combination with trastuzumab to treat advanced HER2+ solid tumor cancers. 

About ACTR707ACTR707 was developed from Unum’s novel proprietary Antibody-Coupled T cell Receptor (ACTR) platform. ACTR is designed to develop autologous engineered T-cell therapies that combine the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses.

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