Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of
the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic
melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops
of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days
with dose escalation.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
toxicity
Garbe Claus, Prof. Dr.
Principal Investigator
Department of dermatology, university of tuebingen
Germany: Ethics Commission
rM28-001
NCT00204594
October 2005
December 2007
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