Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.