Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

  • STATUS
    Recruiting
  • End date
    Feb 10, 2023
  • participants needed
    145
  • sponsor
    Affimed GmbH
Updated on 19 January 2022
ct scan
cancer
systemic therapy
measurable disease
fungal infection
avid
t-cell lymphoma
peripheral t-cell lymphoma
brentuximab vedotin
mycosis fungoides
anaplastic large cell lymphoma
brentuximab

Summary

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.

Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

Details
Condition Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides
Treatment AFM13
Clinical Study IdentifierNCT04101331
SponsorAffimed GmbH
Last Modified on19 January 2022

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