Table 5.
Clinical trials for cancer treatments associated with single-cell sequencing
| NCT number | Phase | Tumor | Title | Status | Primary outcome measures | Single-cell sequencing-related outcome | Enrollment |
|---|---|---|---|---|---|---|---|
| NCT03117751 | Phase 2|Phase 3 | acute lymphoblastic leukemia and lymphoma | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma | Recruiting | Event-free survival (EFS) of patients with ALL | Single-cell sequencing to monitor somatic mutations in peripheral blood as patients undergo treatment | 1000 |
| NCT04352777 | Phase 2 | breast cancer | Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER + /HER2- Breast Cancer | Recruiting | Changes in serum estrogen (E1 and E2) levels compared to changes in the tumor immune cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition | Changes in tumor immune cell populations will be assessed using scRNA-seq | 30 |
| NCT03984578 | Phase 2 | colorectal cancer | Window of Opportunity Study in Colorectal Cancer | Recruiting | Tumor immune gene expression signature|Pathological regression | Relative proportion/percentage of different immune cell states or immune cell types as inferred from single-cell profiling | 50 |
| NCT04460248 | Phase 2 | diffuse large B cell lymphoma | Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naïve Patients With Diffuse Large B-cell Lymphoma (DLBCL) | Recruiting | Complete response rate | scRNA-seq of tumor tissues | 40 |
| NCT03921021 | Phase 2 | esophagogastric adenocarcinoma | Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma | Recruiting | Overall response rate, as assessed by radiographic imaging | Change from baseline in the tumor-immune microenvironment measured using scRNA-seq | 41 |
| NCT04367025 | Phase 2 | gastric cancer | Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer | Not yet recruiting | Major pathological response (MPR) | Differences in T cell gene expression were detected using scRNA-seq to screen people who were more sensitive to immunotherapy | 70 |
| NCT04656535 | Early Phase 1 | glioblastoma | AB154 Combined With AB122 for Recurrent Glioblastoma | Not yet recruiting | Incidence of treatment-emergent adverse events [safety and tolerability] associated with the combination AB122 and AB154 in patients with recurrent glioblastoma | scRNA-seq of tumor and blood after exposure to AB154 with and without AB122 | 46 |
| NCT03655444 | Phase 1|Phase 2 | head and neck squamous cell carcinoma | Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy | Terminated | Phase I Only: Determine the recommended phase 2 Dose of abemaciclib combined with a fixed dose of nivolumab|Overall survival (OS) rate | scRNA-seq analysis of tumor tissue and blood obtained before and during treatment with abemaciclib and nivolumab | 6 |
| NCT04588038 | Phase 1 | head and neck squamous cell carcinoma | NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery | Not yet recruiting | Proportion of treatment-related adverse events | Gene expression profiling using scRNA-seq | 10 |
| NCT03869034 | Phase 2 | hepatocellular carcinoma | TAI Combined With PD-1 Inhibitor in Locally Advanced, Potentially Resectable HCC | Active, not recruiting | Progression-free survival (PFS) assessed using RECIST 1.1 criteria | Biomarkers of treatment response by single-cell RNA sequencing | 40 |
| NCT03407170 | Phase 2 | melanoma | Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475–161/KEYNOTE-161) | Terminated | Mean fraction of cytotoxic T lymphocytes (FCT) in participants who achieved a response compared with participants who experienced progression | Neoepitope sequencing will be generated based on scRNA-seq | 1 |
| NCT03534635 | Phase 2 | melanoma | Analysis of the Modulation of the Tumor Microenvironment by MK-3475 (Pembrolizumab) Using a Systems Biology Approach (PEMSYS) | Recruiting | Identification of biomarkers using genomics and proteomics tools (scRNA-seq, exome sequencing, and single-cell profiling), multiplexed immunohistochemistry and bioinformatics | Identification of biomarkers using scRNA-seq | 30 |
| NCT03743766 | Phase 2 | melanoma | Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting | Recruiting | Change in LAG3 expression | scRNA-seq | 42 |
| NCT04217317 | Phase 2 | non-Hodgkin lymphoma | CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma | Recruiting | Number of participants who successfully complete the therapy regimen | Single-cell sequencing | 12 |
| NCT04697940 | Phase 1|Phase 2 | non-Hodgkin lymphoma | Decitabine-primed Tandem CD19/CD20 CAR T Cells Treatment in r/r B-NHL | Recruiting | Safety in phase 1 | Analysis of CAR T cell populations from patients using single-cell sequencing to determine distinct subtypes and clonal expansion of infiltrating lymphocytes | 30 |
| NCT04495894 | Early Phase 1 | non-small-cell lung cancer and renal cell carcinoma | Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small-Cell Lung Cancer and Renal Cell Carcinoma | Recruiting | Incidence of blood transfusions among the ketorolac group | scRNA-seq | 76 |