Phase 1 Study of D2C7-IT and 2141-V11 Immunotherapy Delivered Directly into Non-Enhancing Tumor Areas After Surgery for Recurrent Glioblastoma, Followed by Regular Cervical Injections

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining D2C7-IT and 2141-V11 drugs for patients with recurrent glioblastoma rGBM who have had surgery to remove their tumor. This phase 1 trial focuses on treating the non-enhancing tumor area remaining after surgery using a method called convection enhanced delivery CED. The study involves patients with confirmed tumor recurrence and aims to assess both safety over 5 years and efficacy over 6 years. Participants receive a single infusion of D2C7-IT directly into the tumor area over 72 hours, followed by a 7-hour infusion of 2141-V11. Then, they get injections of 2141-V11 under the skin near the neck on the same side as the tumor at weeks 2, 4, 7, and 10, and every 3 weeks until week 49. After one year, if patients benefit and choose to continue, these injections are given every 4 to 6 weeks. During the study, patients will have regular brain MRIs to monitor the tumor area and repeated imaging-guided injections. Researchers will track safety and effectiveness outcomes, including any side effects and tumor response. The study lasts several years, with ongoing treatment and follow-up to evaluate long-term results and patient benefit.

D2C7-IT + 2141-V11 Combination Post-resection in rGBM