Clinical Trials Using Anti-CD30/CD16A Monoclonal Antibody AFM13
Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-CD30/CD16A Monoclonal Antibody AFM13. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Phase II Study to Assess AFM13 in Patients With R / R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
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.
Location: 4 locations
AFM13 in Treating Patients with CD30 Positive Relapsed or Refractory Cutaneous Lymphoma
This phase Ib / IIa trial studies anti-CD30 / CD16A monoclonal antibody AFM13 (AFM13) in treating patients with cutaneous lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Biological therapies, such as AFM13, use substances made from living organisms that may stimulate the immune system in different ways and stop cancer cells from growing.
Location: NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center, New York, New York