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ORIGINAL RESEARCH article
Front. Oncol.
Sec. Neuro-Oncology and Neurosurgical Oncology
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1556450
IGV-001 Cellular Immunotherapy for Newly Diagnosed Glioblastoma: Overcoming the Logistic Challenge
Provisionally accepted
Eric T Wong 1,2* Deus Cielo 1,2* Konstantina Svokos 1,2* Curt Doberstein 1,2* Prakash Sampath 1,2* John E Donahue 1,2* Michael Punsoni 1,2* Nuno Rodrigues 1*
Francesca Rothell 1 Robert Edwards 1* Elaina Wang 1,2* Tori Riccelli 1,2* Carlin Chuck 1,2* Elias A Shaaya 1,2* Rahul Sastry 1,2* Rohaid Ali 1,2* Belinda Shao 1,2* Hael Abdulrazeq 1,2* Felicia W Sun 1,2* Joshua Feler 1,2* Santos E Santos Fontánez 1,2* Natalie Amaral Nieves 1,2* Cody Dobertsein 1,2* Jennifer Dailey 1,2* Christine Yu 1,2* Sasmit Sarangi 1,2* Heinrich Elinzano 1,2* Jerrold L Boxerman 1,2* Esther Yu 1,2* Howard Safran 1,2*
Attila A Seyhan 3 Wafik El- Deiry 1,2*
Sharonda Keith 1 Ziya L Gokaslan 1,2* Clark C Chen 1,2* Athar Malik 1,2*- 1 Rhode Island Hospital, Providence, Rhode Island, United States
- 2 Warren Alpert Medical School, Brown University, Providence, Rhode Island, United States
- 3 Brown University, Providence, Rhode Island, United States
Background: IGV-001 is a type of cellular immunotherapy currently being investigated for treating glioblastoma (NCT04485949). It uses the patient's tumor to elicit an autologous immune response.Methods: The process involves (i) craniotomy for maximum safe resection of the glioblastoma, (ii) ex-vivo treatment of the tumor with an anti-sense oligonucleotide against insulin-like growth factor 1 receptor followed by irradiation, (ii) placement of the treated tumor in multiple biodiffusion chambers, which are implanted into the patient's abdominal sheath to elicit an immune response, and (iii) explantation of the chambers 48 hours later. The clinical trial was open at 32 sites in the United States, and eligible subjects were randomized in a 2:1 ratio to receive biodiffusion chambers containing either conditioned glioblastoma tissue or a placebo. Patients subsequently proceeded to standard-of-care treatment with concomitant radiation-temozolomide, followed by 6 cycles of adjuvant temozolomide.Results: The execution of the IGV-001 protocol procedure is complicated and involves a multistep process requiring mobilization of multiple services within the cancer center of a tertiary care hospital, including neurosurgery, neuro-oncology, radiation oncology, neuroradiology, cancer clinical trial office, and operating room personnel to fulfill the pre-specified protocol requirements in a timely fashion.Conclusions: We have learned a great deal in the process of developing and executing our internal procedures for this clinical trial. Our description of the IGV-001 protocol workflow may serve as a "blueprint" for future implementation of this type of cellular immunotherapy at other centers. We further discuss some of the lessons we have learned during the trial.
Keywords: IGV-001, cellular immunotherapy, Glioblastoma, Logistics, Bio-diffusion Chambers
Received: 06 Jan 2025; Accepted: 14 Feb 2025.
Copyright: © 2025 Wong, Cielo, Svokos, Doberstein, Sampath, Donahue, Punsoni, Rodrigues, Rothell, Edwards, Wang, Riccelli, Chuck, Shaaya, Sastry, Ali, Shao, Abdulrazeq, Sun, Feler, Santos Fontánez, Nieves, Dobertsein, Dailey, Yu, Sarangi, Elinzano, Boxerman, Yu, Safran, Seyhan, El- Deiry, Keith, Gokaslan, Chen and Malik. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Eric T Wong, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Deus Cielo, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Konstantina Svokos, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Curt Doberstein, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Prakash Sampath, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
John E Donahue, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Michael Punsoni, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Nuno Rodrigues, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Robert Edwards, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Elaina Wang, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Tori Riccelli, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Carlin Chuck, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Elias A Shaaya, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Rahul Sastry, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Rohaid Ali, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Belinda Shao, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Hael Abdulrazeq, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Felicia W Sun, Warren Alpert Medical School, Brown University, Providence, 02912, Rhode Island, United States
Joshua Feler, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Santos E Santos Fontánez, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Natalie Amaral Nieves, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Cody Dobertsein, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Jennifer Dailey, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Christine Yu, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Sasmit Sarangi, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Heinrich Elinzano, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Jerrold L Boxerman, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Esther Yu, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Howard Safran, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Wafik El- Deiry, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Ziya L Gokaslan, Warren Alpert Medical School, Brown University, Providence, 02912, Rhode Island, United States
Clark C Chen, Rhode Island Hospital, Providence, 02903, Rhode Island, United States
Athar Malik, Warren Alpert Medical School, Brown University, Providence, 02912, Rhode Island, United States
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