Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28

University Hospital Tuebingen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Melanoma

Treatments: Drug: rM28; Drug: autologous PBMCs

Study type: Interventional

Funder types: Other

Identifiers

NCT00204594

rM28-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• malignant melanoma stage III/IV
• injectable soft tissue metastasis
• informed consent given
• Karnofsky >= 70%

Exclusion criteria

• additional chemotherapeutical treatment
• systemic glucocorticoids
• brain metestasis
• other malignancies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Antibody

Experimental group

Treatment:

Drug: rM28

Drug: autologous PBMCs