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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204594

Enrollment

Registered

2005-09-20

Start date

2005-10-31

Completion date

2007-12-31

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

mRNA, vaccination, melanoma

Brief summary

Detailed 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.

Interventions

DRUGrM28

DRUGautologous PBMCs

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
toxicity	—
clinical response	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026