NCT04277221

ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)

Status unknown Phase 3 Last updated 17 March 2020

What this trial tests

Phase 3 trial testing Autologous Dendritic Cell/Tumor Antigen, ADCTA in Glioblastoma Multiforme in 118 participants. Status unknown.

Timeline

19 September 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	19 September 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	7 locations across Taiwan

Drugs / interventions tested

• Autologous Dendritic Cell/Tumor Antigen, ADCTA — full drug profile →

Conditions studied

• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

Safe Save Medical Cell Sciences & Technology Co.,Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Exploiting innate immunity for cancer immunotherapy.
   Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w
4. Recurrent Glioblastoma: From Molecular Landscape to New Treatment Perspectives.
   Birzu C, French P, Caccese M, Cerretti G, et al · · 2020 · cited 141× · PMID 33375286 · DOI 10.3390/cancers13010047
5. Trial watch: Dendritic cell (DC)-based immunotherapy for cancer.
   Laureano RS, Sprooten J, Vanmeerbeerk I, Borras DM, et al · · 2022 · cited 101× · PMID 35800158 · DOI 10.1080/2162402x.2022.2096363
6. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
7. Immune Escape in Glioblastoma Multiforme and the Adaptation of Immunotherapies for Treatment.
   Pearson JRD, Cuzzubbo S, McArthur S, Durrant LG, et al · · 2020 · cited 92× · PMID 33178210 · DOI 10.3389/fimmu.2020.582106
8. Glioblastoma Immune Landscape and the Potential of New Immunotherapies.
   Daubon T, Hemadou A, Romero Garmendia I, Saleh M. · · 2020 · cited 89× · PMID 33154756 · DOI 10.3389/fimmu.2020.585616