Table 2.
Active trials involving myeloid cell-based therapies/vaccines
| NCT | Phase | Intervention | Target population | Location | Sample size | Key outcomes |
|---|---|---|---|---|---|---|
| NCT00639639 | Phase I | CMV pp65-LAMP mRNA-loaded DC vaccine with or without autologous lymphocyte transfer | Newly diagnosed glioblastoma, during recovery from TMZ-induced lymphopenia | USA | 42 | Feasibility and safety of DC vaccine, immune responses, DC tracking |
| NCT01204684 | Phase II | Autologous tumor lysate-pulsed DC vaccine alone, with resiquimod, or with poly:ICLC | Newly diagnosed or recurrent high-grade glioma, prior resection at recruiting center | USA | 60 | Most effective combination of vaccine components, PFS, OS |
| NCT01567202 | Phase II | RT/TMZ plus DC vaccine loaded with glioma stem cell antigens vs with placebo vaccine | Newly diagnosed glioblastoma, IDH1 wt, TERT mutated | China | 100 | ORR, OS, PFS |
| NCT02010606 | Phase I | Antigens taken from GSC cells lines, pulsed with autologous patient DCs, in conjunction with TMZ/RT or optional bevacizumab depending on cohort | Newly diagnosed or recurrent glioblastoma | USA | 39 | Safety and tolerability, adverse events, PFS, OS, T cell activity |
| NCT02366728 | Phase II | Adjuvant tetanus toxoid preconditioning followed by human CMV pp65-LAMP mRNA-pulsed autologous DC vaccine | Newly diagnosed glioblastoma, recently resected | USA | 64 | mOS, DC migration to lymph nodes, mOS/mPFS in CMV-seropositive vs seronegative patients |
| NCT02649582 | Phase I/II | Autologous WT1 mRNA-loaded DC vaccine given after resection, with adjuvant TMZ | Newly diagnosed glioblastoma | Belgium | 20 | Safety and feasibility of vaccine production, adverse events, immunological response, clinical efficacy |
| NCT02820584 | Phase I | Autologous tumor GSC lysate-loaded DCs alone | Newly diagnosed glioblastoma | Italy | 20 | Safety, vaccine production, OS |
| NCT03395587 | Phase II | Autologous tumor lysate-loaded DC vaccine with adjuvant RT/TMZ vs standard of care | Newly diagnosed glioblastoma, IDH wt | Germany | 136 | OS, PFS, adverse events, functional outcome |
| NCT03548571 | Phase II/III | Trivalent DC vaccine (survivin, hTERT, autologous tumor stem cell antigens) followed by TMZ, vs standard therapy alone | Newly diagnosed glioblastoma, IDH wt, MGMT unmethylated | Norway | 60 | OS, PFS, immunological response, adverse events |
| NCT03866109 | Phase I/II | CD34-enriched hematopoietic stem cells and progenitor cells that express IFN-a2 | Newly diagnosed glioblastoma, MGMT-unmethylated | USA | 21 | Tolerability and safety, hematologic recovery, max dose, PFS, OS, functional outcomes |
| NCT03879512 | Phase I/II | Autologous tumor lysate-loaded DC vaccine, with prior cyclophosphamide (Treg depletion), with nivolumab/ipilimumab dual therapy followed by nivolumab monotherapy | Recurrent high-grade glioma in children and adolescents | Germany | 25 | OS, PFS, toxicity, Treg numbers, T cell responses, pathology correlation |
| NCT03927222 | Phase II | CMV pp65-LAMP mRNA-loaded DCs with GM-CSF, TMZ, and Td toxoid | Newly diagnosed glioblastoma, MGMT unmethylated, CMV seropositive | USA | 48 | mOS, DC cell migration, cytokine expression, Treg increase, toxicity |
| NCT04201873 | Phase I | Tumor lysate-loaded DC vaccine, pembrolizumab, poly-ICLC vs placebo/DC vaccine/poly-ICLC | Recurrent or progressive glioblastoma | USA | 40 | Cell cycle signature, expansion of TCR clones, adverse events, PFS, OS |
| NCT04277221 | Phase III | Autologous DC vaccine loaded with tumor lysate with and without bevacizumab | Recurrent glioblastoma | Taiwan | 118 | OS, PFS |
| NCT04388033 | Phase I/II | DC/glioma fusion vaccine plus IL-12 plus TMZ in the adjuvant phase | Newly diagnosed, recently resected glioblastoma | China | 10 | Adverse events, OS, PFS |
| NCT04552886 | Phase I | TH-1 personalized DC vaccine with TMZ/RT after resection | Newly diagnosed glioblastoma | USA | 24 | Safety, toxicity, OS, PFS |
| NCT04801147 | Phase I | Autologous tumor lysate-loaded DC vaccine after resection and TMZ/RT | Newly diagnosed glioblastoma | Italy | 76 | PFS, adverse events, immune response |
| NCT04888611 | Phase II | Camrelizumab (anti-PD-1) with GSC antigen-loaded DC vaccine, vs placebo | Recurrent glioblastoma | China | 40 | OS, PFS, adverse events, exploratory biomarkers |
| NCT04963413 | Phase I | Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF, with TMZ maintenance | Newly diagnosed glioblastoma, recently completed TMZ/RT | USA | 10 | Safety and feasibility of generating vaccine doses |