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Table 3 Available clinical trials of nanomaterials-based tumor immunotherapy

From: Nanomaterials in tumor immunotherapy: new strategies and challenges

Nanomaterials

Cargo molecules

Indications

Stage

Results

Reference

Cyclodextrin polymer-based nanoparticle

Small interfering RNA to reduce the expression of the M2 subunit of ribonucleotide reductase

Melanoma;

Gastrointestinal cancer;

Prostate cancer

Phase Ia/Ib

The pharmacokinetics of CALAA-01 in humans show fast elimination and reveal that the maximum concentration obtained in the blood after i.v. administration correlates with body weight across all species

[312]

Poly-ICLC, a double-stranded RNA complex that consists of poly(I:C) (polyinosinic: polycytidylic acid) stabilized by poly-L-lysine

cholesteryl pullulan and NY-ESO-1 antigen protein

advanced or recurrent esophageal cancer

phase I

Comparing CHP-NY-ESO-1 alone to the poly-ICLC combination, all patients exhibited antibody responses, but the titers were higher in the combination group

[313]

Poly-ICLC, a double-stranded RNA complex that consists of poly(I:C) (polyinosinic: polycytidylic acid) stabilized by poly-L-lysine

NY-ESO-1 antigen protein and montanide

high-risk resected melanoma

phase I/II

The combination with poly-ICLC is safe, well tolerated, and capable of inducing integrated antibody and CD4 + T-cell anti-tumor immune responses

[314]

Cholesteryl pullulan (CHP)-antigen protein nanoparticle

NY-ESO-1 antigen protein

esophageal cancer

phase I (NCT01003808)

The safety and immunogenicity of CHP-NY-ESO-1 vaccine were confirmed

[315]

Nanogels of cholesteryl pullulan

HER2 protein 1–146

Solid cancer expressed HER2

phase I

CHP-HER2 vaccine was well tolerated; HER2-specific CD8( +) and/or CD4( +) T-cell immune responses were detected

[316]

Nanoparticle albumin

Nanoparticle albumin-bound (nab)-paclitaxel & atezolizumab (anti-PD-L1 antibody)

Unresectable locally advanced or metastatic triple-negative

phase 3 trial (NCT02425891)

Nanoparticle albumin-bound (nab)-paclitaxel may enhance the anticancer activity of atezolizumab; the median progression-free survival was 7.5 months with atezolizumab plus nab-paclitaxel, as compared with 50 months with placebo plus nab-paclitaxel in patients with PD-L1 positive expression; the median overall survival was 25.0 months with atezolizumab plus nab-paclitaxel and 15.5 months with placebo plus nab-paclitaxel in patients with PD-L1 positive expression

[317]

Poly (beta-amino ester)-based nanomaterial

Plasmids encoding a 194-1BBz CAR and a piggyBac transposase

To be determined

Phase 1 projected 2020–2021

DNA-carrying nanoparticles can efficiently introduce leukaemia-targeting CAR genes into T-cell nuclei, thereby bringing about long-term disease remission

[318]

IL-15 super-agonist complex nanogel

IL-15 superagonist complex

Solid cancer and lymphomas

Phase 1

Nanogels delivery selectively expanded T cells 16-fold in tumors and allowed at least eight-fold higher doses of cytokine to be administered without toxicity in tumor microenvironment

[319]