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A Phase I Dose-escalation Study to Assess the Safety of AFM11 (CD19 x CD3 TandAb) in Patients With Relapsed or Refractory Adult B-precursor Acute Lymphoblastic Leukemia

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Trial Profile

A Phase I Dose-escalation Study to Assess the Safety of AFM11 (CD19 x CD3 TandAb) in Patients With Relapsed or Refractory Adult B-precursor Acute Lymphoblastic Leukemia

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2023

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At a glance

  • Drugs AFM 11 (Primary)
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions
  • Sponsors Affimed Therapeutics

    • Most Recent Events

    • 03 Jan 2023 Results (n=16; AFM11-101 and n=17; AFM11-102) assessing the safety of AFM11 in the treatment of patients with B-cell malignancies from NCT02106091 and NCT02848911 studies, published in the Trials.
    • 17 Jun 2019 Status changed from suspended to discontinued.
    • 17 Apr 2019 According to an Affimed N.V media release, the company today announced that it has submitted to the U.S. Food and Drug Administration (FDA) additional information (clinical trial protocol) to Affimed initial response document submitted in early March relating to the previously announced clinical hold on AFM11. Affimed anticipates receiving a response from the FDA regarding the status of the AFM11 clinical program in the second quarter of 2019.

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