Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 7:10 PM
Study NCT ID:
NCT06622434
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
New Adjuvant Vaccine in Glioblastoma, a Phase 1/2a Study (NAVIG-1)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVIG-1
Brief Summary:
This phase I/II trial evaluates the safety and the immunological efficacy of a cancer vaccine against 2 glioma-associated antigens in newly-diagnosed glioblastomas. All patients enrolled in the study will receive standard treatment consisting of surgical resection of the tumor followed by radio-chemotherapy. Immunotherapy will begin 4 weeks after the completion of radiotherapy.
Detailed Description:
This therapeutic vaccine targeting 2 identified glioma-associated antigens (TERT and PTPRZ1) is based on a new formulation that contains synthetic melanin and a TLR9 agonist, which is caable to induce strong cellular immune responses.
One month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide. Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months for a total of 12 months.
Phase 1: subcutaneous injections at one of 3 pre-specified dose levels of peptides Phase 2a: subcutaneous injections at the dose selected in the phase 1 part. Safety will be evaluated clinically and with blood samples at each treatment visit. Efficacy will be assessed with anti-PTPRZ1 and anti-TERT specific T cell responses in peripheral blood, and with cerebral MRI every other months
One month after glioblastoma patients have completed the initial phase of treatment with concurrent radiochemotherapy, patients will be immunized during the adjuvant phase of monthly temozolomide. Immunizations will follow the standard schedule of a priming phase (D0, W2, W4, and W6) followed by a boost phase with one immunization every 2 months for a total of 12 months.
Phase 1: subcutaneous injections at one of 3 pre-specified dose levels of peptides Phase 2a: subcutaneous injections at the dose selected in the phase 1 part. Safety will be evaluated clinically and with blood samples at each treatment visit. Efficacy will be assessed with anti-PTPRZ1 and anti-TERT specific T cell responses in peripheral blood, and with cerebral MRI every other months
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-514567-26-00 | CTIS | None | View |