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NCT04968366
Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery
Phase 1 trial testing Autologous dendritic cells pulsed with multiple neoantigen peptides. in Glioblastoma Multiforme of Brain in 11 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2024
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 30 July 2021 |
| Primary completion | 30 April 2024 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Autologous dendritic cells pulsed with multiple neoantigen peptides. — full drug profile →
- Temozolomide adjuvant chemotherapy — full drug profile →
Conditions studied
- Glioblastoma Multiforme of Brain — all drugs for Glioblastoma Multiforme of Brain →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 18 to 75, any sex, with Glioblastoma Multiforme of Brain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccine to treat adult postoperative patients with newly-diagnosed glioblastoma, in combination with the standard-of-care Temozolomide (TMZ) chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoantigens: promising targets for cancer therapy.
Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x -
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 -
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 -
Impaired function of dendritic cells within the tumor microenvironment.
Xiao Z, Wang R, Wang X, Yang H, et al · · 2023 · cited 61× · PMID 37441069 · DOI 10.3389/fimmu.2023.1213629 -
Immunotherapeutic Strategies for the Treatment of Glioblastoma: Current Challenges and Future Perspectives.
Salvato I, Marchini A. · · 2024 · cited 32× · PMID 38610954 · DOI 10.3390/cancers16071276 -
Dendritic cell vaccines improve the glioma microenvironment: Influence, challenges, and future directions.
Zhou J, Li L, Jia M, Liao Q, et al · · 2023 · cited 26× · PMID 36464889 · DOI 10.1002/cam4.5511 -
Dendritic cell subsets and implications for cancer immunotherapy.
Chen MY, Zhang F, Goedegebuure SP, Gillanders WE. · · 2024 · cited 24× · PMID 38903502 · DOI 10.3389/fimmu.2024.1393451 -
Trial watch: anticancer vaccination with dendritic cells.
Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
Verify or expand the search:
- PubMed search for NCT04968366
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Glioblastoma Multiforme of Brain
Currently open trials in the same condition.
- NCT06815432 — GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma · Phase 1 · recruiting
- NCT06613841 — Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma · EARLY_PHASE1 · recruiting
- NCT06283927 — The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) · recruiting
- NCT06273176 — The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma · recruiting
- NCT06146725 — The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202) · recruiting
Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
- NCT07341854 — Dexamethasone Palmitate for Postoperative Pain · NA · not yet recruiting
- NCT07527013 — Stratified Blood Pressure Management Strategy After Endovascular Treatment for Acute Ischemic Stroke · Phase 3 · not yet recruiting
- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04968366 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 11 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04968366.
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