DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)

Summary

The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone. Participants in the DOC1021 + pIFN + SOC arm will: * Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection * Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses * Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections Both arms of the trial will: \- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation

Timeline

Start

2025-03-17

Primary completion

2030-03

Completion

2032-03

Publications

• Georges JF, Clay C, Amin S, Goralczyk A, Mossop C, Bilbao CJ, Valeri A, Ifrach J, Zaher M, Colman L, Kohler L, Schumann EH, Vu M, Burns BA, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste KJ, Bisht N, Vazquez-Perez J, Oyewole-Said D, Amanya SB, Rodriguez V, Kraushaar DC, Okoebor D, Bellayr I, Hartenbach J, Halpert MM, Duus EM, Aguilar LK, Hsu SH, Zhu JJ, Zvavanjanja RC, Bai Y, Kang SW, Jang HJ, Lee HS, Garg R, Esquenazi Y, Tandon N, Turtz A, Konduri V, Decker WK. Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. medRxiv [Preprint]. 2026 Apr 2:2026.03.28.26349013. doi: 10.64898/2026.03.28.26349013.

Drugs

Indications