M.D. Anderson Cancer Center
The proposed study is a single arm Phase I trial aimed at treating up to 6 HLA-A\*0201+ and HLA-A\*24 02+ individuals with leptomeningeal disease from metastatic melanoma.
Primary Objective: Evaluate the safety of adoptively transferred intrathecal ETC targeting melanoma tumors in patients with leptomeningeal disease. Secondary Objectives: 1. Evaluate the duration of in vivo persistence (peripheral blood and CSF) and anti-tumor efficacy achieved following adoptive transfer of antigen specific ETC. 2. Overall survival for up to one year after end of patient monitoring. Primary Endpoint: Safety and Toxicity Evaluation Secondary Endpoint: 1. Persistence of transferred T cells. 1. The numeric and functional persistence of transferred CTL will be performed…
Inclusion Criteria: 1. Patients must have radiographic and/or CSF cytological evidence of LMD. 2. Must have a confirmed diagnosis of primary CNS melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal, or mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted. 3. Male or female subjects ≥18 years of age. 4. Expression of HLA-A2 or HLA-A24. 5. ECOG/ Zubrod performance status ≤1 at screening visit for this treatment 6. Ability to understand and the willingness to sign a written informed consent document.…
Given by infusion
Arctuva estimate
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