Wong Eric T, Cielo Deus, Svokos Konstantina, Doberstein Curt, Sampath Prakash, Donahue John E, Punsoni Michael, Rodrigues Nuno, Rothell Francesca, Edwards Robert, Wang Elaina, Riccelli Tori, Chuck Carlin, Shaaya Elias A, Sastry Rahul, Ali Rohaid, Shao Belinda, Abdulrazeq Hael, Sun Felicia W, Feler Joshua, Santos Fontánez Santos E, Nieves Natalie Amaral, Dobertsein Cody, Dailey Jennifer, Yu Christine, Sarangi Sasmit, Elinzano Heinrich, Boxerman Jerrold L, Yu Esther, Safran Howard, Seyhan Attila A, El-Deiry Wafik S, Keith Sharonda, Gokaslan Ziya L, Chen Clark C, Malik Athar
Division of Hematology/Oncology, Department of Medicine and Brown University Health Cancer Institute, Rhode Island Hospital and The Warren Alpert Medical School of Brown University, Providence, RI, United States.
Department of Neurology, Rhode Island Hospital and The Warren Alpert Medical School of Brown University, Providence, RI, United States.
Front Oncol. 2025 Mar 18;15:1556450. doi: 10.3389/fonc.2025.1556450. eCollection 2025.
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.
The process involves (i) craniotomy for maximum safe resection of the glioblastoma, (ii) treatment of the tumor with an anti-sense oligodeoxynucleotide against insulin-like growth factor 1 receptor followed by irradiation, (iii) placement of the treated tumor in multiple bio-diffusion chambers, which are implanted into the patient's abdominal sheath to elicit an immune response, and (iv) 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 bio-diffusion 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.
The execution of the IGV-001 protocol procedure is complicated and involves a multi-step 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.
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.
IGV - 001是一种目前正在研究用于治疗胶质母细胞瘤的细胞免疫疗法（NCT04485949）。它利用患者的肿瘤引发自体免疫反应。
该过程包括（i）进行开颅手术以最大程度安全切除胶质母细胞瘤，（ii）用针对胰岛素样生长因子1受体的反义寡脱氧核苷酸处理肿瘤，随后进行放疗，（iii）将处理后的肿瘤放置在多个生物扩散室中，这些生物扩散室植入患者的腹直肌鞘以引发免疫反应，以及（iv）48小时后取出这些生物扩散室。该临床试验在美国的32个地点开展，符合条件的受试者按2:1的比例随机分组，以接受含有经处理的胶质母细胞瘤组织或安慰剂的生物扩散室。患者随后接受标准治疗，同步进行放疗 - 替莫唑胺治疗，随后进行6个周期的辅助替莫唑胺治疗。
IGV - 001方案程序的执行很复杂，涉及多个步骤，需要调动三级护理医院癌症中心内的多项服务，包括神经外科、神经肿瘤学、放射肿瘤学、神经放射学、癌症临床试验办公室和手术室人员，以便及时满足预先规定的方案要求。
在为该临床试验制定和执行内部程序的过程中，我们学到了很多东西。我们对IGV - 001方案工作流程的描述可作为其他中心未来实施此类细胞免疫疗法的“蓝图”。我们进一步讨论了在试验过程中吸取的一些经验教训。
