Table II.

List of Exosomes and Exosome-Based Liquid Biopsy Clinical Trials (CT) in Immune Oncology (www.clinicaltrials.gov)

NCT number	Title	Status	Conditions	Interventions	Phase
NCT01159288	Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes	Completed	Non-small cell lung cancer (NSCLC)	Sequential treatment of chemotherapeutic agent; metronomic cyclophosphamide (mCTX) or mCTX and immunotherapy using antigen-loaded dendritic cell-derived exosomes (Dex).	Phase 2
NCT04427475	Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer	Recruiting	NSCLC	This CT explores response of immunotherapy (pablolizumab and nafulizumab) by measuring the PD-L1 and miRNA levels in plasma exosomes in pre- and post-treated patients and correlate it with the treatment outcome.	Not applicable
NCT02869685	Clinical Research for the Consistency Analysis of PD-L1 in Lung Cancer Tissue and Plasma Exosome Before and After Radiotherapy	Unknown status	NSCLC	This CT is based on the premise that radiation therapy can enhance the effect of immunotherapy. The study involves measuring PD-L1 expression levels in tissues and plasma exosomes (pExo) of patients before and after radiation treatment.	Not applicable
NCT02890849	Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome	Unknown status	NSCLC	This CT tends to explore the consistency of PD-L1 levels in cancer tissues and plasma exosomes (pExo) so that pExo can be utilized as a modality to monitor response of radiotherapy and immunotherapy.	Not applicable
NCT02507583	Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma	Active, not recruiting	Malignant glioma	This CT uses the unique property of exosomes where they carry tumor antigens. The investigators of the study planted exosomes along with an anti-	Phase 1
NCT02439008	Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Immune Response	Terminated	Hepatocellular carcinoma, colorectal neoplasms melanoma kidney neoplasms	To use blood plasma derived exosomes (nanovesicles) collected before, during, and after radiation therapy to determine the treatment response and develop a liquid biopsy modality	Not applicable
NCT01550523	Pilot Immunotherapy Trial for Recurrent Malignant Gliomas	Completed	Malignant glioma of the brain	This CT is based on similar premise of NCT02507583 described above. The modification included in this study is use of a new oligodeoxynucleotide sequence and treatment at initial diagnosis	Phase 1
NCT03985696	Exosomes and Immunotherapy in Non-Hodgkin B-cell Lymphomas	Recruiting	Lymphoma, B cell, aggressive non-Hodgkin (B-NHL)	This CT explores the role of exosomes in immunotherapy escape by investigating therapeutic targets CD20, and PDL-1 carried by exosomes derived from B cell non-Hodgkin lymphoma (B-NHL) cells. The CT also evaluates exosome composition for identification of potential diagnostic markers	Not applicable
NCT03854032	Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck	Recruiting	oral cavity, larynx, hypopharynx, nasal cavity/paranasal sinuses, stage 1 oropharyngeal with lymphadenopathy	This CT basically explores the therapeutic efficacy of nivolumab and BMS986205 in combination or as standalone therapy. Exosome content and the number of exosomes present in peripheral blood will be used to assess the interactions between the immune and metabolic microenvironment. The exosomes will be isolated before, during, and after treatment.	Phase 2