NCT07414979

Phase 1 Study Of Intrathecal Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells For Patients With Leptomeningeal Melanoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 on CSF samples (where available) and peripheral blood obtained from patients prior to T cell infusion (baseline sample), and as scheduled above. The numeric frequency of transferred T cells will be determined using peptide MHC-tetramer analysis or specific CDR3 TCR quantitative PCR of transferred CTL if necessary. The function of transferred CTL will be determined by intracellular cytokine staining of tetramer+ CD8+ cells following in vitro stimulation. 2. Tetramer analysis. Since all patients on study will be HLA-A2+ and HLA-A24+, the use of tetramers to track several well-characterized tumor-associated HLA-A2 and HLA-A24-restricted responses will be feasible. These include responses to several melanosomal antigens: (tyrosinase, MART1/MelanA, gp100, SLC45A2) and CT antigens: (PRAME, MAGE-A1, MAGE-A10). Flow-based tetramer staining permits multiparametric analysis such that surface markers of differentiation (CD62L, CCR7, CD27, CD28) can be used to further characterize the effector, effector memory or central memory phenotype of the induced population of antigen-specific T cells. 2. Overall survival

Conditions

• Leptomeningeal Melanoma

Interventions

Type	Name	Description
DRUG	CD8+T cells	Given by infusion

Timeline

• Start date: 2026-08-31
• Primary completion: 2028-03-22
• Completion: 2030-03-22
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study