Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients
Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
|---|---|
| Enthalten in: |
Future oncology (London, England) - 20(2024), 10 vom: 22. März, Seite 579-591 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Lee, Ian Y [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 20.03.2024 Date Revised 27.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT04485949 Citation Status MEDLINE |
|---|
| doi: |
10.2217/fon-2023-0702 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM365512370 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM365512370 | ||
| 003 | DE-627 | ||
| 005 | 20240327235512.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.2217/fon-2023-0702 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1351.xml |
| 035 | |a (DE-627)NLM365512370 | ||
| 035 | |a (NLM)38060340 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Lee, Ian Y |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 20.03.2024 | ||
| 500 | |a Date Revised 27.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04485949 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Goldspire™ | |
| 650 | 4 | |a IGV-001 | |
| 650 | 4 | |a antisense | |
| 650 | 4 | |a autologous | |
| 650 | 4 | |a glioblastoma | |
| 650 | 4 | |a immunotherapy | |
| 650 | 4 | |a radiation | |
| 650 | 4 | |a temozolomide | |
| 650 | 7 | |a Temozolomide |2 NLM | |
| 650 | 7 | |a YF1K15M17Y |2 NLM | |
| 650 | 7 | |a Oligonucleotides, Antisense |2 NLM | |
| 650 | 7 | |a IGV-001 |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents, Alkylating |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 700 | 1 | |a Hanft, Simon |e verfasserin |4 aut | |
| 700 | 1 | |a Schulder, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Judy, Kevin D |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, Eric T |e verfasserin |4 aut | |
| 700 | 1 | |a Elder, J Bradley |e verfasserin |4 aut | |
| 700 | 1 | |a Evans, Linton T |e verfasserin |4 aut | |
| 700 | 1 | |a Zuccarello, Mario |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Julian |e verfasserin |4 aut | |
| 700 | 1 | |a Aulakh, Sonikpreet |e verfasserin |4 aut | |
| 700 | 1 | |a Agarwal, Vijay |e verfasserin |4 aut | |
| 700 | 1 | |a Ramakrishna, Rohan |e verfasserin |4 aut | |
| 700 | 1 | |a Gill, Brian J |e verfasserin |4 aut | |
| 700 | 1 | |a Quiñones-Hinojosa, Alfredo |e verfasserin |4 aut | |
| 700 | 1 | |a Brennan, Cameron |e verfasserin |4 aut | |
| 700 | 1 | |a Zacharia, Brad E |e verfasserin |4 aut | |
| 700 | 1 | |a Silva Correia, Carlos Eduardo |e verfasserin |4 aut | |
| 700 | 1 | |a Diwanji, Madhavi |e verfasserin |4 aut | |
| 700 | 1 | |a Pennock, Gregory K |e verfasserin |4 aut | |
| 700 | 1 | |a Scott, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Perez-Olle, Raul |e verfasserin |4 aut | |
| 700 | 1 | |a Andrews, David W |e verfasserin |4 aut | |
| 700 | 1 | |a Boockvar, John A |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Future oncology (London, England) |d 2005 |g 20(2024), 10 vom: 22. März, Seite 579-591 |w (DE-627)NLM161450725 |x 1744-8301 |7 nnns |
| 773 | 1 | 8 | |g volume:20 |g year:2024 |g number:10 |g day:22 |g month:03 |g pages:579-591 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.2217/fon-2023-0702 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 20 |j 2024 |e 10 |b 22 |c 03 |h 579-591 | ||