Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Completed · Phase 2
Conditions studied: Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides
In brief
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 overall 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.
Key facts
- Study ID
- NCT04101331
- Run by
- Affimed GmbH
- People needed
- 108
- Starts
- 2019-11-13
- Expected to finish
- 2024-01-11
- Last updated by the study team
- 2024-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- University of California Los Angeles (UCLA) Health — Los Angeles, California, United States
- Emory University Clinic/Winship Cancer Institute — Atlanta, Georgia, United States
- Ochsner Clinic Foundation/Precision Cancer Therapies Program — New Orleans, Louisiana, United States
- University of Michigan Health | Rogel Cancer Center — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Center for Lymphoid Malignancies — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Washington Seattle Cancer Care Alliance — Seattle, Washington, United States
- Royal Adelaide Hospital — Adelaide, Australia
- Flinders Medical Centre — Bedford Park, Australia
- Monash Health-Monash Medical Centre — Clayton, Australia
- Concord Repatriation General Hospital — Concord, Australia
- Gosford Hospital — Gosford, Australia
- Linear Clinical Research — Nedlands, Australia
- Centre Hospitalier Universitaire (CHU) de Bordeaux — Bordeaux, France
- Centre Hospitalier Universitaire de Brest — Brest, France
- CHD Vendée — La Roche-sur-Yon, France
- CHU Pontchaillou — Rennes, France
- Institut Gustave Roussy — Villejuif, France
- Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH — Essen, Germany
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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