Abstract Details

Title DOC1021 Cell-based Immunotherapy in Combination With Standard Chemoradiation for Adjuvant Therapy of Glioblastoma: Early Results From an Expanded Access Protocol of a Phase I Trial

Topic Neuro-oncology

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 6-010

Objective

To report ongoing results of an expanded access protocol evaluating DOC1021 in adult patients with new or recurrent glioblastoma.

Background Glioblastoma is a highly lethal malignancy with median overall survival of 12 months in real-world population studies using standard of care (SOC) therapies and ~14-21 months in clinical trial settings. DOC1021 is a dendritic cell (DC)-based immunotherapeutic derived from the full complement of autologous tumor antigens. It leverages p38MAPK and mTORC1 signaling cascades to initiate cDC1-like differentiation of monocyte-derived DCs, generating highly cytotoxic CD8⁺ memory effectors.

Design/Methods DOC1021 was prepared from mobilized peripheral blood mononuclear cells, loaded consecutively with autologous amplified tumor mRNA and tumor lysate. Following resection and chemoradiation, DOC1021 was injected bilaterally near the deep cervical node chains every other week for 3 doses (36 x 106 total cells), administered concurrently with 6 weekly doses of interferon. Patients were treated from November 2024 through July 2025, and follow-up is ongoing.

Results Seven patients (5 newly diagnosed, 2 recurrent) received all 3 planned doses of DOC1021 after surgical resection and SOC (median age: 57.0 years; 5/7 MGMT unmethylated). The most common DOC1021-related adverse events were mild injection site reactions. One patient developed grade 3 cerebral edema after the first DOC1021 dose, recovered, and completed subsequent doses as planned, reflecting a transient treatment-emergent immune response and/or aggressive dexamethasone taper. At the time of this analysis, all patients remain alive, with post-operative survival from the time of second surgery of 13 and 18 months for the first recurrent 2 patients and ongoing for the newly diagnosed cohort. Exploratory correlative studies are also ongoing.

Conclusions Administration of DOC1021 after resection and SOC is safe, feasible, and potentially efficacious in patients diagnosed with glioblastoma, confirming Phase I trial results. A multi-center, randomized, open-label Phase 2 trial for newly diagnosed glioblastoma patients (NCT06805305) is now enrolling.

Authors/Disclosures
Jay-Jiguang Zhu, MD, PhD, FAAN (Univ of Texas Health Science Center in Houston) PRESENTER	The institution of Dr. Zhu has received research support from Novocure, Inc. The institution of Dr. Zhu has received research support from ABM Therapeutics Corporation . The institution of Dr. Zhu has received research support from Chimerix Inc.
Yoshua Esquenazi, MD	Dr. Esquenazi has nothing to disclose.
Sigmund H. Hsu, MD (New York Hospital)	No disclosure on file
Mia Vu, CRC	Miss Vu has nothing to disclose.
Rodrick C. Zvavanjanja, MD	Dr. Zvavanjanja has nothing to disclose.
Akshar J. Trivedi, MS	Mr. Trivedi has nothing to disclose.
Wei Liu, MD	Ms. Liu has nothing to disclose.
Madhuri S. Namekar, MS	Mrs. Namekar has nothing to disclose.
Keenan Ernste	Mr. Ernste has received intellectual property interests from a discovery or technology relating to health care.
Nitin Tandon	Nitin Tandon has stock in BrainDynamics. The institution of Nitin Tandon has received research support from NIH.
Eva H. Schumann	Ms. Schumann has received personal compensation for serving as an employee of Diakonos Oncology.
Elizabeth Duus, PhD	Ms. Duus has received personal compensation for serving as an employee of Diakonos Oncology.
Laura Aguilar, MD, PhD	Dr. Aguilar has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Diakonos Oncology. An immediate family member of Dr. Aguilar has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Candel Therapeutics. Dr. Aguilar has stock in Candel Therapeutics .
Joseph Georges, DO, PhD	Dr. Georges has received intellectual property interests from a discovery or technology relating to health care.
Vanaja konduri, PhD	Dr. konduri has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Diakonos Oncology. Dr. konduri has stock in Diakonos Oncology. The institution of Dr. konduri has received research support from Diakonos Oncology.
William K. Decker, PhD	Dr. Decker has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Diakonos Oncology Corp.. Dr. Decker has stock in Diakonos Research, Ltd.. The institution of Dr. Decker has received research support from NIH. The institution of Dr. Decker has received research support from ALSF. The institution of Dr. Decker has received research support from Cancer Cures 4 Kids. Dr. Decker has received intellectual property interests from a discovery or technology relating to health care.

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