Finding studies
Finding studies
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Lead
Case Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. Assess the safety and toxicity profile of repeated infusions of ex-vivo activated tumor-draining lymphocytes (X-ACT) in participants with advanced melanoma. SECONDARY OBJECTIVES: I. Assess the feasibility of multiple infusions of X-ACT. II. Assess the effect of dose and schedule on immunologic parameters using two novel biomarkers. III. Observe the clinical outcomes of participants receiving X-ACT therapy. OUTLINE: This is a dose-escalation study. STEP 1: Participants undergo lymph node biopsy for collection of at least one melanoma-draining lymph node (MDLN). MDLN cells will then be cryopreserved into aliquots until they are needed to generate an activated T cell culture. STEP 2: Cryopreserved lymph node cells are thawed and then undergo activation with anti-cluster of differentiation (CD)3/anti-CD28 microbeads. The cultures then undergo expansion over 14-18 days in the presence of recombinant human interleukin-2 and anti-vascular endothelial growth factor antibody. The activated X-ACT cells are then transferred i.v. into the same participant from which they were derived with no additional therapy.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
