NCT04911621: ADDICT-pedGLIO

Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma

Active, enrolled Phase 1, PHASE2 Last updated 8 May 2024

What this trial tests

Phase 1, PHASE2 trial testing Dendritic cell vaccination + temozolomide-based chemoradiation in High Grade Glioma in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 September 2021

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	University Hospital, Antwerp
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	10 September 2021
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	1 location across Belgium

Drugs / interventions tested

• Dendritic cell vaccination + temozolomide-based chemoradiation — full drug profile →
• Dendritic cell vaccination +- conventional next-line treatment — full drug profile →

Conditions studied

• High Grade Glioma — all drugs for High Grade Glioma →
• Diffuse Intrinsic Pontine Glioma — all drugs for Diffuse Intrinsic Pontine Glioma →

Sponsor

University Hospital, Antwerp

Who can join

Adults 12 Months to 17, any sex, with High Grade Glioma or Diffuse Intrinsic Pontine Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Childhood aggressive gliomas are rare brain tumors with very poor prognosis. Due to the tumor's location and infiltrative nature, surgical removal is not always possible, and even when resection is performed and combined with chemo- and/or radiotherapy, tumor cells frequently persist, eventually giving rise to tumor recurrence. A promising strategy to eradicate persisting tumor cells is vaccination with dendritic cells (DC). DC are immune cells that play an important role in organizing the body's defense against cancer. The goal of DC vaccination is to activate these natural anti-tumor defense mechanisms to delay or prevent tumor progression or recurrence. Previous clinical studies have demonstrated that DC vaccination is well-tolerated, safe and capable of eliciting tumorspecific immunity.

A clinical study including 10 pediatric patients (aged ≥ 12 months and \< 18 years at the time of signing the informed consent) with brain (stem) tumors is initiated at the Antwerp University Hospital to investigate intradermal vaccination with WT1 mRNA-loaded autologous monocyte-derived DCs, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies. The general objective of this phase I/II clinical study is (1) to demonstrate that WT1-targeted DC vaccine production and administration in pediatric patients with HGG and DIPG, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies, is feasible and safe, (2) to study vaccine-induced immune responses, (3) to document patients' quality of life and clinical outcome for comparison with current patients' outcome allowing indication of the added value.

Publications & conference data

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

1. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment.
   Lorentzen CL, Haanen JB, Met Ö, Met Ö, et al · · 2022 · cited 362× · PMID 36174631 · DOI 10.1016/s1470-2045(22)00372-2
2. A Comprehensive Review of mRNA Vaccines.
   Gote V, Bolla PK, Kommineni N, Butreddy A, et al · · 2023 · cited 263× · PMID 36769023 · DOI 10.3390/ijms24032700
3. 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
4. mRNA vaccine in cancer therapy: Current advance and future outlook.
   Li Y, Wang M, Peng X, Yang Y, et al · · 2023 · cited 78× · PMID 37612832 · DOI 10.1002/ctm2.1384
5. The intrinsic and microenvironmental features of diffuse midline glioma: Implications for the development of effective immunotherapeutic treatment strategies.
   Persson ML, Douglas AM, Alvaro F, Faridi P, et al · · 2022 · cited 58× · PMID 35481923 · DOI 10.1093/neuonc/noac117
6. Advancements in clinical RNA therapeutics: Present developments and prospective outlooks.
   Saw PE, Song E. · · 2024 · cited 38× · PMID 38744276 · DOI 10.1016/j.xcrm.2024.101555
7. mRNA vaccines in the prevention and treatment of diseases.
   Gu Y, Duan J, Yang N, Yang Y, et al · · 2022 · cited 38× · PMID 36033422 · DOI 10.1002/mco2.167
8. RNA modification in mRNA cancer vaccines.
   Mei Y, Wang X. · · 2023 · cited 34× · PMID 36788153 · DOI 10.1007/s10238-023-01020-5