Yeast-based immunotherapy for chordoma
a technology of immunotherapy and chordoma, applied in the field of yeast-based immunotherapy compositions and methods, can solve the problems of limiting the ability to safely re-irradiate, few reports of treatment protocols and outcomes for recurrent lesions, complex removal of tumor itself is not a satisfactory treatment goal, etc., to achieve the effect of preventing chordoma, and reducing the risk of recurren
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example 2
[0146]The following example describes a phase 2 clinical trial in healthy subjects with a history of familial chordoma.
[0147]A randomized phase 2 clinical trial in healthy subjects with a history of familial chordoma (i.e. subjects from a family with two or more blood relatives with a history of chordoma) is run using a yeast-Brachyury immunotherapeutic composition as described herein (e.g., a yeast-Brachyury immunotherapeutic composition comprising a whole, heat-killed Saccharomyces yeast that has expressed SEQ ID NO:8 or SEQ ID NO:20). At least 40 or more subjects are enrolled.
[0148]The trial is run as a double-blind or open-label, placebo-controlled, multi-center trial. All patients receive routine monitoring, with treatment arm patients receiving several serial injections of yeast-Brachyury immunotherapeutic composition. Subjects are monitored for the occurrence of chordoma. Endpoints can include antigen-specific T cell responses (e.g., Brachyury-specific CD8+ T cells emerging o...
example 3
[0150]The following example describes a phase 1 clinical trial conducted in subjects with cancers known to express Brachyury.
[0151]An open-label, sequential dose-escalation, phase 1 clinical trial was initiated using the yeast-Brachyury immunotherapy composition referred to as GI-6301. Under this clinical trial protocol, the key inclusion criteria included presence of a solid tumor, measurable disease (disease must be evaluable) or non-measurable disease, Eastern Cooperative Oncology Group (ECOG) status grade of 0-1 (wherein grade 0 indicates fully active, able to carry on all pre-disease performance without restriction and grade 1 indicates restricted in physically strenuous activity but ambulatory and able to carry work of a light or sedentary nature), creatinine levels of 1500, platelet count of >100,000, minimum of 2 weeks from prior chemotherapy treatment. In addition, patients that had prior immune therapy were allowed.
[0152]The key exclusion criteria included patients having ...
example 4
[0157]The following example describes an expansion of the Phase 1 study described in Example 3 showing results from immunization of subjects with chordoma using a yeast-Brachyury composition of the invention.
[0158]An expansion phase of the Phase 1 study described in Example 3was initiated. The goal of the expansion phase was to administer GI-6301 at the highest tolerated dose to an additional cohort of patients, and to include advanced chordoma patients in the study. To enroll the expansion phase, the following eligibility criteria were removed as compared to the initial study described in Example 3: exclusion of CNS disease (specifically to allow for chordoma patients to enroll), thyroid disease (and monitoring) and Epstein-Barr virus (EBV) PCR requirements.
[0159]Seven patients with recurrent (advanced) chordoma were enrolled onto the 40 Y.U. dose level expansion phase and the clinical and immunological outcomes of these patients have been initially evaluated All seven patients had...
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