Table 4.
The clinical studies of neoantigen-based immunotherapies
| Neoantigen-based immunotherapies | Therapeutic strategies | Cancer types | Clinical Trail Numbers (Primary Outcome Measures) |
|---|---|---|---|
| Cancer vaccines | |||
| Dendritic cell vaccine | Dendritic cell vaccine | Breast cancer, colorectal cancer, diffuse intrinsic pontine glioma, glioblastoma, gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, esophagus cancer, HPV-positive cancer, melanoma, gastrointestinal cancer, ovarian cancer, pancreatic cancer | NCT04105582 (One-year safety and adverse events (AEs)), NCT04879888 (AEs), NCT01885702 (5-years safety), NCT03914768 (2-years safety and overall survival (OS) at 12 months (OS12)), NCT05317325 (AEs), NCT05023928 (AEs), NCT04147078 (5-years disease-free survival (DFS)), NCT03674073 (One-year safety and AEs), NCT03870113 (AEs and immunogenicity), NCT03300843 (Clinical response rates), NCT03871205 (AEs and immunogenicity), NCT02956551 (AEs), NCT04078269 (Safety and tolerability), NCT03205930 (AEs), NCT05270720 (AEs), NCT01278940 (Safety and toxicity) |
| Dendritic cell vaccine + ACTs | Melanoma, bladder cancer, colorectal cancer | NCT05235607 (AEs) | |
| Dendritic cell vaccine + chemical drug | Advanced biliary tract malignant tumor, acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, non-hodgkin’s lymphoma, glioblastoma multiforme | NCT02632019 (2-years OS), NCT00923910 (AEs), NCT04968366 (AEs) | |
| Dendritic cell vaccine + ICBs | Hepatocellular carcinoma, colorectal cancer liver metastases | NCT04912765 (2-years relapse free survival) | |
| Dendritic cell vaccine + chemical drug + ICBs | Lymphocytic leukemia | NCT03219450 (One-year safety) | |
| Dendritic cell vaccine + TILs | Fallopian tube cancer, ovarian cancer, primary peritoneal cancer | NCT03735589 (AEs and dose-limiting toxicities (DLTs)) | |
| DNA vaccine | DNA vaccine | Glioblastoma, melanoma, pancreatic cancer, pediatric recurrent brain tumor, lynch syndrome, non-small cell lung carcinoma | NCT04015700 (Safety and tolerability), NCT03655756 (Serious adverse events (SAEs) and DLTs), NCT03122106 (Safety), NCT03988283 (Safety and tolerability), NCT05078866 (AEs and immunogenicity), NCT04990479 (Safety and tolerability) |
| DNA vaccine + ICBs | HPV 16-positive oropharynx cancer, small cell lung cancer, prostate cancer, renal cell carcinoma, triple-negative breast cancer, solid tumors, hepatocellular carcinoma | NCT04001413 (5 years clearance rates of HPV), NCT04397003 (Safety and tolerability), NCT03532217 (Safety, tolerability, and clinical response rates), NCT03598816 (Safety), NCT03199040 (Safety), NCT04251117 (AEs and immunogenicity), NCT05354323 (AEs) | |
| mRNA vaccine | mRNA vaccine | Melanoma, colon cancer, gastrointestinal cancer, genitourinary cancer, hepatocellular cancer, esophageal cancer, non-small cell lung cancer, triple negative breast cancer | NCT02410733 (AEs), NCT03480152 (Clinical response rates and AEs), NCT05198752 (DLTs), NCT02035956 (Safety and tolerability), NCT03908671 (AEs), NCT02316457 (AEs) |
| mRNA vaccine + ICBs | Melanoma, non-small cell lung cancer, bladder cancer, colorectal cancer, triple negative breast cancer, renal cancer, head and neck cancer, pancreatic cancer, solid tumors | NCT03289962 (DLTs and AEs), NCT04267237 (62-months DFS), NCT03897881 (3-years recurrence-free survival (RFS)), NCT03948763 (DLTs and AEs), NCT03313778 (AEs) | |
| mRNA vaccine + ICBs + Chemical drug | Pancreatic cancer | NCT04161755 (Toxicity) | |
| Peptide vaccine | Peptide vaccine | Melanoma, non-small cell lung cancer, pancreatic cancer, pediatric brain tumor, colorectal cancer, breast cancer, head and neck squamous cell carcinoma, liver cancer, diffuse intrinsic pontine glioma, glioblastoma, glioblastoma multiforme, astrocytoma, acute lymphoblastic leukemia, esophageal cancer, lynch syndrome, bladder urothelial carcinoma | NCT03662815 (Clinical response rates and AEs), NCT01970358 (AEs), NCT04509167 (WBC and RBC changes), NCT04397926 (Safety), NCT05013216 (Toxicity), NCT03956056 (Safety), NCT05111353 (Safety), NCT03068832 (Safety and tolerability), NCT04087252 (Safety), NCT05238558 (Delayed type hypersensitivity (DTH), proliferative T-cell responses and AEs), NCT03552718 (AEs), NCT04749641(Safety and one-year survival rate), NCT05356312 (NA), NCT02510950 (Safety and tolerability), NCT03559413 (Clinical response), NCT02992977 (AEs), NCT05307835 (One-year relapse-free survival and AEs), NCT04943718 (AEs), NCT03807102 (AEs and 2-years DFS), NCT03715985 (AEs), NCT04998474 (Immunogenicity), NCT04810910 (AEs and 4 years-relapse free survival), NCT03673020 (AEs), NCT03645148 (Objective response rate (ORR) and AEs), NCT03558945 (2-years overall survival) |
| Peptide vaccine + ICBs | Breast cancer, colorectal cancer, pancreatic cancer, melanoma, advanced solid tumor, diffuse intrinsic pontine glioma, diffuse midline glioma, non-small cell lung cancer, head and neck squamous cell, fibrolamellar hepatocellular carcinoma, follicular lymphoma, glioblastoma, hepatocellular carcinoma, urothelial carcinoma, renal cell carcinoma, bladder urothelial cancer, gastrointestinal tract cancer, myeloproliferative neoplasms, squamous cell lung cancer, gastroesophageal adenocarcinoma, urothelial carcinoma, ovarian cancer, platinum-resistant fallopian tube carcinoma, primary peritoneal carcinoma | NCT04864379 (ORR and AEs), NCT05269381 (AEs), NCT05098210 (AEs), NCT03606967 (6- and 12-months progression-free survival (PFS)), NCT02600949 (AEs), NCT03597282 (AEs), NCT04072900 (AEs and Clinical response), NCT04117087 (AEs), NCT04943848 (Safety and Tolerability), NCT03633110 (AEs), NCT04248569 (Toxicity), NCT03361852 (Clinical response), NCT03422094 (Safety and Tolerability), NCT03568058 (AEs), NCT03359239 (AEs), NCT05153304 (AEs), NCT02950766 (DLTs), NCT03929029 (DLTs), NCT04930783 (DLTs), NCT04364230 (Safety and immunogenicity), NCT05444530 (DLTs and AEs), NCT03166254 (Safety), NCT04266730 (AEs), NCT03639714 (AEs, SAEs, DLTs and ORR), NCT03953235 (AEs, SAEs, DLTs and ORR), NCT04024878 (AEs and SAEs), NCT04799431 (Toxicity), NCT03206047 (AEs and one-year PFS), NCT02897765 (AEs and SAEs) | |
| Peptide vaccine + chemical drug | Non-small cell lung cancer, smoldering plasma cell myeloma | NCT04487093 (AEs), NCT03631043 (AEs) | |
| Peptide vaccine + ICBs + chemical drug | Non-small cell lung cancer | NCT03380871 (AEs and SAEs) | |
| Peptide vaccine + ICBs + chemical drug + Radiotherapy | Glioblastoma | NCT02287428 (AEs) | |
| Adoptive cell therapy (ACT) | |||
| TCR-T cell | TCR-T cell | Gynecologic cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer, cholangiocarcinoma, endometrial cancer, ovarian carcinoma, squamous cell lung cancer, adenocarcinoma of lung, adenosquamous cell lung cancer, hepatocellular carcinoma, advanced malignant solid tumor, melanoma, advanced solid tumor | NCT05194735 (DLTs, ORR and AEs), NCT05105815 (18-months DFS), NCT04625205 (AEs and SAEs), NCT03171220 (AEs), NCT05020119 (AEs and DLTs) |
| TCR-T cell + chemical drug | Endocrine/neuroendocrine,non-small cell lung cancer, breast cancer, gastrointestinal/genitourinary cancers, ovarian cancer, melanoma, head and neck squamous cell carcinoma, urothelial carcinoma, renal cell carcinoma, small-cell lung cancer, cutaneous squamous cell carcinoma, anal squamous cell carcinoma, merkel cell carcinoma, vaginal cancer, cervical cancer, anal cancer, penile cancer, oropharyngeal cancer | NCT04102436 (Response rate), NCT04596033 (AEs), NCT02280811 (DLTs and ORR), NCT02858310 (Overall response rate and AEs) | |
| TCR-T cell + ICBs | Malignant epithelial neoplasms, solid tumor | NCT05349890 (AEs and SAEs), NCT04520711 (Safety, tolerability and DLTs), NCT03970382 (DLTs and AEs) | |
| TCR-T cell + ICB + chemical drug | Endocrine tumors, non-small cell lung cancer, ovarian cancer, breast cancer, gastrointestinal /genitourinary cancers, neuroendocrine tumors, multiple myeloma, Hpv-16 positive squamous cell anal cancer | NCT03412877 (Response rate), NCT04536922 (Treatment effect) | |
| TCR-T cell + radiotherapy | Hepatocellular carcinoma | NCT03199807 (AEs) | |
| TILs | TILs | Malignant epithelial tumors, malignant solid tumor | NCT05141474 (AEs, SAEs and treatment-limiting toxicity (TLT)) |
| TILs + chemical drug | Gastric cancer, colorectal cancer, pancreatic cancer, gall bladder cancer, esophageal cancer, recurrence tumor, metastatic cancer, solid tumor | NCT04426669 (Maximum tolerated dose (MTD)), NCT03658785 (ORR), NCT02959905 (AEs) | |
| TILs + ICBs | Melanoma, advanced non-small cell lung cancer | NCT03997474 (AEs), NCT04032847 (AEs) | |
| TILs + ICBs + chemical drug | Non-small cell lung cancer, squamous cell carcinoma, adenosquamous carcinoma | NCT03215810 (DLTs) | |
| CAR-T | CAR-T therapy + Chemical drug | Glioblastoma multiforme | NCT02844062 (Safety) |
| Immune checkpoint blockade (ICB) | |||
| ICBs | ICBs | Acute myeloid leukemia, myelodysplastic syndrome, bladder cancer, melanoma, colon cancer, glioma, glioblastoma, head and neck squamous cell carcinoma, HPV16-positive cancer, locally recurrent cancer, nasopharyngeal carcinoma, non-small cell lung cancer, oesophageal cancer, prostate cancer, rectal cancer, uterine cancer | NCT03600155 (Optimal dose), NCT02553642 (ORR), NCT03827044 (3-years DFS), NCT03718767 (6-months PFS), NCT03925246 (24-weeks PFS), NCT03082534 (ORR), NCT03357757 (Treatment effect), NCT03813394 (2-years ORR and PFS), NCT02437279 (Safety), NCT04825990 (ORR), NCT03130764 (Clinical response), NCT03653052 (Clinical response), NCT02113657 (Clinical response), NCT03040791 (Clinical response), NCT04019964 (Clinical response), NCT04293419 (Clinical response), NCT04262089 (Clinical response) |
| ICB + chemical drug | Acute myeloid leukemia, bladder cancer, breast cancer, colorectal cancer, hormone receptor positive tumor, endometrium cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, triple-negative breast cancer, peritoneal cancer, fallopian tube cancer, prostate cancer, head and neck squamous cell carcinoma | NCT04214249 (Clinical response), NCT03978624 (Clinical response), NCT02990845 (8-months PFS rate), NCT02453620 (AEs), NCT03409198 (3-years toxicity and PFS), NCT05456165 (AEs), NCT05201612 (10-months ORR), NCT03832621 (8-month PFS), NCT03186326 (12-months PFS), NCT04659382 (9-months PFS), NCT04262687 (10-months PFS), NCT05141721 (5-years PFS), NCT04014530 (AEs and ORR), NCT03918499 (Safety), NCT03655002 (DLTs and AEs), NCT03126812 (Clinical response), NCT03554317 (Clinical response), NCT04336943 (Clinical response), NCT04068194 (MTD and ORR), NCT05317000 (Clinical response), NCT02883062 (tumor infiltrating lymphocyte (TIL) percentage) | |
| ICB + radiotherapy | Cutaneous T cell lymphoma | NCT03385226 (Overall response rate) | |
| ICB + chemical drug + radiotherapy | Colorectal cancer, meningioma, rectal cancer | NCT03854799 (Rate of complete pathologic response), NCT03604978 (MTD, AEs and ORR), NCT04340401 (Rate of complete pathologic response) | |