個別化がんワクチンの臨床試験で安全性と免疫活性を確認(Clinical Trial of Personalized Cancer Vaccine Demonstrates Feasibility, Safety, Immune Activation)

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2025-12-12 ハーバード大学

Harvard 大学 Wyss Institute と Dana-Farber Cancer Institute が共同で実施した初の ヒトを対象とした第I相臨床試験「WDVAX」 は、個別化されたバイオマテリアルベースのがんワクチンの実現可能性、安全性、および免疫活性化効果を示した。このワクチンは、患者自身の腫瘍由来抗原と免疫活性物質を含む多孔性生体分解性スキャフォールドで構成され、免疫系の中心的役割を担う樹状細胞を誘引・活性化する仕組みを持つ。試験はステージ4の転移性メラノーマ患者21名を対象に行われ、ワクチンの製造プロセスが実臨床で実行可能であることが示され、重大な治療関連有害事象は確認されなかった。また、単剤ワクチン療法で全体の43%の患者が病勢安定を示し、免疫系の活性化が確認された。この結果は、将来的に免疫チェックポイント阻害剤との併用などを含む新たながん免疫療法の開発につながる可能性を示している。WDVAX 試験の成果は Cancer Immunology Research に公表された。

個別化がんワクチンの臨床試験で安全性と免疫活性を確認(Clinical Trial of Personalized Cancer Vaccine Demonstrates Feasibility, Safety, Immune Activation)
The personalized biomaterial-based cancer vaccine consists of a porous biomaterial scaffold the size of an aspirin tablet that is infused with immune cell-recruiting and activating molecules and inactivated tumor antigens derived from tumors of the trial participants. Credit: Wyss Institute at Harvard University

<関連情報>

転移性黒色腫患者を対象とした、自己腫瘍細胞溶解液を含む樹状細胞活性化スキャフォールドWDVAXを用いたワクチン接種のヒト初臨床試験 First-in-Human Clinical Trial of Vaccination with WDVAX, a Dendritic Cell–Activating Scaffold Incorporating Autologous Tumor Cell Lysate, in Patients with Metastatic Melanoma

F. Stephen HodiCorresponding Author;Anita Giobbie-Hurder;Kwasi Adu-Berchie;Srin Ranasinghe;Ana Lako;Mariano Severgnini;Emily M. Thrash;Jason L. Weirather;Joanna Baginska;Michael P. Manos;Edward J. Doherty;Alexander Stafford;Heather Daley;Jerome Ritz;Patrick A. Ott;Kathleen L. Pfaff;Scott J. Rodig;Charles H. Yoon;Glenn Dranoff;David J. Mooney
Cancer Immunology Research  Published:July 02 2025
DOI:https://doi.org/10.1158/2326-6066.CIR-24-0333

Abstract

The optimal means to prime for effective antitumor immunity in a patient with cancer remain elusive in the current era of checkpoint blockade. Crafting a strategy to amplify the number and function of CD8+ T cells while blocking regulatory cells should increase immunotherapy efficacy. Biomaterial carriers have been demonstrated in preclinical studies to amplify the effects of immunomodulatory agents, synergistically integrate the effects of different agents, and concentrate and manipulate immune cells in vivo. Herein, we report data from a phase I trial in patients with metastatic melanoma who received the cytokine GM-CSF and the innate Toll-like receptor 9 agonist CpG oligonucleotide admixed with autologous tumor lysate onto a microporous poly-lactide-co-glycolide matrix polymer scaffold that achieves precise control over the spatial and temporal release of immunostimulatory agents in vivo. This materials system (WDVAX) served as a physical antigen-presenting structure to which dendritic cells and other immune-stimulating cells are recruited and activated. In this first clinical trial of a macroscale biomaterial–based vaccine, WDVAX treatment was found to be feasible and to induce immune activation in patients with melanoma.

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