Summary of available clinical trials on nanomaterials-based tumor immunotherapy
| Nanomaterials | Cargo molecules | Indications | Clinical stage | Key findings | References |
|---|---|---|---|---|---|
| Cyclodextrin polymer-based nanoparticle | Small interfering RNA targeting the M2 subunit of ribonucleotide reductase | Melanoma, gastrointestinal cancer, prostate cancer | Phase Ia/Ib | CALAA-01 pharmacokinetics revealed that peak concentration and exposure correlate with body weight across species. | [241] |
| Poly-L-lysine, double-stranded RNA complex with polyinosinic-polycytidylic acid | NY-ESO-1 antigen protein | Advanced or recurrent esophageal cancer | Phase I | Combination of CHP-NY-ESO-1 with poly-ICLC induced superior antigen-specific T-cell responses compared to monotherapy. | [242] |
| Poly-L-lysine, double-stranded RNA complex with polyinosinic-polycytidylic acid | NY-ESO-1 antigen protein + monomide | High-risk resected melanoma | Phase I/II | The CHP-NY-ESO-1 combination was well tolerated and effectively induced integrated CD4+ and CD8+ T-cell responses. | [243] |
| Poly-L-lysine pullulan (CHP) nanoparticle | NY-ESO-1 antigen protein | Esophageal cancer | Phase I (NCT01003868) | Tumor immunogenicity of the CHP-NY-ESO-1 vaccine was confirmed, showing promising therapeutic potential. | [244] |
| Nanoparticle albumin | HER2 protein 1–146 | HER2-expressing solid cancer | Phase I | HER2-specific CD8+ T-cell responses were successfully detected in patients. | [245] |
| Nanoparticle albumin-bound (nab)-paclitaxel + atezolizumab (anti-PD-L1 antibody) | - | Unresectable locally advanced or metastatic triple-negative breast cancer | Phase III (NCT02425891) | Median progression-free survival was 7.5 months in PD-L1 positive patients treated with the nanoparticle-bound atezolizumab combination. | [246] |
| Poly (beta-amino ester) based nanomaterial | Plasmids encoding 19.4-1 BBZ CAR and a piggybac transposase | To be determined | Phase I (projected 2020–2021) | Efficient introduction of DNA plasmids leading to sustained disease remission with long-term therapeutic benefits. | [247] |
| IL-15 super-agonist complex | IL-15 super-agonist complex nanogel | Solid cancer and lymphomas | Phase I | The IL-15 super-agonist nanogel enabled high local cytokine concentrations while maintaining minimal systemic toxicity. | [248] |
PD-L1: programmed death-ligand 1
Note. Adapted from “Nanomaterials in tumor immunotherapy: new strategies and challenges” by Zhu X, Li S. Mol Cancer. 2023;22:94 (https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-023-01797-9). CC BY.