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A phase 2 study of AFM13, a bispecific cell engager targeting CD30 and CD16A, in patients with CD30-positive PTCL or transformed mycosis fungoides




TAP Partner

Project Term: August 26, 2013 - June 30, 2020

In August 2013, LLS began its first European partnership with Affimed that supported two clinical trials for Hodgkin lymphoma (HL) patients. Expanding upon the initial work supported by LLS TAP, Affimed is currently enrolling "A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)." AFM13 is bispecific tetravalent Innate Cell Engager (ICE®) targeting CD30 on tumor cells and CD16A on NK cells and macrophages. Building on the success of the two trials in HL, the company received FDA approval to enroll patients in a Phase 2 registration-directed study of AFM13 as a monotherapy in relapsed or refractory CD30-positive peripheral T-cell lymphoma. Concurrently, the study is enrolling patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T-cell lymphoma. The REDIRECT clinical trial is currently enrolling patients. 

Lay Abstract

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