Clinical Trials Logo
  1. Home
  2. Glioblastoma Multiforme of Brain
  3. NCT04968366

Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

Glioblastoma Multiforme of Brain Clinical Trial

Official title:
Phase I Clinical Study of Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

Clinical Trial Summary

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.

Clinical Trial 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 vaccination for the treatment of newly-diagnosed glioblastoma (GBM). The subjects are adult GBM patients who have undergone surgical resection. After the completion of TMZ concurrent chemoradiation, and, during conventional adjuvant TMZ chemotherapy, subjects will receive autologous DC vaccine treatments as scheduled. Ten subjects will be enrolled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.d) to subjects. After 5 injections, the investigator will review subject's tolerance and compliance, and decide whether or not to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of TMZ adjuvant chemotherapy to assess patient's immune response. According to the result, investigators will be decided whether to perform more 1-2 treatment cycles (5-8 infections/cycle) to strengthen the effectiveness. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04968366
Study type Interventional
Source Beijing Tiantan Hospital
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 30, 2021
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03657576 - Trial of C134 in Patients With Recurrent GBM Phase 1
Recruiting NCT05685004 - Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM) Phase 2/Phase 3
Recruiting NCT05076513 - Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma Early Phase 1
Active, not recruiting NCT03665545 - Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma Phase 1/Phase 2
Completed NCT02474966 - Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme: a Pilot Study Phase 2
Active, not recruiting NCT02137759 - MRSI to Predict Response to RT/TMZ ± Belinostat in GBM Phase 2
Enrolling by invitation NCT03170141 - Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme Phase 1
Recruiting NCT04842513 - Multi Peptide Vaccination With XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma Phase 1
Recruiting NCT04869449 - Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas Early Phase 1
Recruiting NCT03633552 - Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma Phase 3
Not yet recruiting NCT05095441 - A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma Phase 1
Completed NCT00003456 - Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme Phase 2
Completed NCT03047473 - Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme Phase 2
Enrolling by invitation NCT05116137 - The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors N/A
Recruiting NCT05627323 - CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma Phase 1
Suspended NCT04222309 - Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM) Phase 1
Not yet recruiting NCT06186440 - Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma Phase 1/Phase 2
Recruiting NCT06146725 - The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
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