Multi-antigen T Cell Infusion Against Neuro-oncologic Disease

Summary

This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B). Pediatric and adult patients who have high-risk CNS tumors known to typically have positivity for one or more Tumor Antigen Associated (TAA) (WT1, PRAME and/or Survivin) will be eligible. TAA-T will all be generated from patient peripheral blood mononuclear cells (PBMC). Group A patients (DIPG): The first TAA-T dose will be infused any time 14 days or more after completion of radiotherapy. Group B patients (other recurrent/progressive/refractory CNS tumors): The first TAA-T dose will be infused any time 14 days or more after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria.

Timeline

Start

2018-12-12

Primary completion

2028-03

Completion

2028-12

Outcome

Met primary endpoint

paper This trial met safety/feasibility primary end points with some preliminary signals of efficacy. PMID 42380677 ↗

Publications

• Gomez S, DiCioccio RA, Geiger AE, Grant ML, Reynolds E, Datar A, McCann CD, Tanna J, Kukadiya D, Hoq F, Zhang A, Hanley PJ, Webb JL, Kilburn LB, Rood BR, Fonseca A, Meany HJ, Vezina LG, Packer RJ, Cruz CRY, Bollard CM, Hwang EI. Multi-antigen-targeting T cells in pediatric central nervous system tumors: a phase 1 trial. Nat Med. 2026 Jun 30. doi: 10.1038/s41591-026-04449-9. Online ahead of print.

Drugs

Indications