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Table 2 Active trials involving myeloid cell-based therapies/vaccines

From: Translational landscape of glioblastoma immunotherapy for physicians: guiding clinical practice with basic scientific evidence

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