A commercial-stage immunotherapy company developing cytokine and cellular immunotherapies designed to restore immune competence, today announced updated Phase 2 clinical results from QUILT 3.078 (NCT06061809), evaluating a chemotherapy-free combination immunotherapy regimen in patients with second-line recurrent or progressive glioblastoma (GBM), as well as patients treated under single-patient INDs (spINDs) across first- to third-line disease.
QUILT-3.078 enrolled patients with recurrent GBM at first recurrence. In the spIND population, seven patients were first line and are alive to date. Randomised clinical trials for both first line and second line+ GBM patients are in development.
QUILT-3.078 Phase 2 Results to Date
As of January 22, 2026, the study has enrolled 23 patients with recurrent or progressive GBM who progressed following standard-of-care therapy, including surgery, radiation, and temozolomide-based chemotherapy. 19 of the 23 enrolled patients remain alive, with four deaths reported to date.
Of the 23 enrolled patients, 14 currently have evaluable clinical data and comprise the efficacy population for the current analysis. Among these evaluable patients, a total of 139 doses of combination immunotherapy have been administered. The median follow up is 6 months in the evaluable cohort. All four deaths to date occurred within the evaluable cohort, and median overall survival has not yet been reached.
“Across contemporary studies, median overall survival for patients with recurrent glioblastoma is approximately six to nine months. Outcomes beyond this benchmark remain uncommon, underscoring the substantial unmet medical need in this disease. The patients enrolled in this study represent a particularly challenging population, having progressed after standard therapies and with severe lymphopenia. Observing ongoing treatment durability, survival beyond historical expectations in some patients, and a manageable safety profile without chemotherapy represents a paradigm change in the treatment of patients with glioblastoma,” said Simon Khagi, M.D., MBA, Medical Director of Neuro Oncology at the Hoag Family Cancer Institute and Principal Investigator. Updated clinical findings will be presented by Dr. Simon Khagi at the Stand Up to Cancer Glioblastoma Innovation Scientific Summit on January 31, 2026 in Pasadena, Calif., including the focus on immune agonists as a combination backbone and the ImmunityBio Bioshield regimen.
Immune competence and lymphocyte recovery
At study entry, patients demonstrated immune compromise consistent with prior standard of care, including radiation and alkylating chemotherapy. The baseline mean absolute lymphocyte count (ALC) was approximately 900 cells per µL, consistent with lymphopenia commonly observed after prior therapy in recurrent GBM.
“These Phase 2 data reflect outcomes in a second- and third-line glioblastoma population where immune collapse after standard therapy is common and options are limited. With 19 of 23 enrolled patients alive and median overall survival not yet reached, the survival profile warrants continued follow up,” said Patrick Soon Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “It has been extensively reported that patients with glioblastoma and lymphopenia have a significant decreased survival. Current standards of care, including radiation and chemotherapy (temozolomide), are potent drivers of lymphocyte depletion. The patients that entered this study all suffered profound lymphopenia, reflected by a baseline mean ALC of approximately 900, consistent with prior radiation and chemotherapy exposure. On treatment, we observed recovery and maintenance of lymphocyte counts without chemotherapy. Notably, within this broader clinical and compassionate use experience, we have also observed a near complete response with survival extending beyond twelve months from the time of documented disease progression, an outcome rarely seen in recurrent glioblastoma.”
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