A Phase 1/2 interventional study of AlloStim in Hepatocellular Carcinoma, sponsored by Mirror Biologics, Inc.. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Mirror Biologics, Inc. · Phase 1/2, Interventional, and Treatment
This study is an individualized anti-cancer vaccine protocol where the vaccination occurs inside of the body. To create the vaccine, a tumor lesion is selected and caused to die by a process called "Radiofrequency Ablation" or RFA. RFA causes the tumor to release its internal contents to the surrounding environment, such contents include tumor-specific antigens. Immune cells respond to the tissue damage and take-up these tumor antigens. The injection of the experimental cell drug, AlloStim(TM) into the lesion is designed to cause the responding cells to signal the immune system of the danger of the tumor, creating tumor-specific immunity.
The protocol design has 4 steps: (1) priming; (2) vaccination, (3) activation and (4) boosting. The priming step involves intradermal injections of AlloStim(TM). This is designed to increase the circulating titer of allo-specific Th1 memory cells; the vaccination step involves percutaneous radiofrequency ablation of a single liver lesion followed immediately with an intratumoral injection of AlloStim(TM) into the ablated lesion, followed 3 days later by an additional intratumoral injection into the previously ablated lesion with AlloStim(TM). This step is designed to elicit tumor-specific Th1 immunity. The activation step involves intravenous infusions of AlloStim(TM). This step is designed to cause the activation and extravasation of circulating memory cells and the activation of innate immune cells. The booster step includes two monthly IV infusions of AlloStim(TM). This step is designed to maintain an inflammatory cytokine storm designed to counteract immune suppressor mechanisms and tumor immunoavoidance mechanisms.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
Browse Carcinoma studies →Mirror Biologics, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Intradermal AlloStim(TM) (1ml) on day 0 and 3 in same location Intradermal AlloStim(TM) (1ml) on day 7 and day 10 in same location Radiofrequency ablation on day 14 followed by intralesional AlloStim (3ml) Intralesional AlloStim(TM)(3ml) on day 17 in same ablated lesion Intravenous AlloStim(TM)(5ml) on days 21, 49 and 78
Biological: AlloStim
allogeneic Th1 memory cell with CD3/CD28-coated microbeads attached.
Also known as: InSituVax
Safety
Subjects will be followed by physical exam, blood labs, CT scan and biopsy for any adverse events
Time frame: baseline to 90 days
Tumor-Specific Immunity
Determine if the in-situ vaccine elicits detectable tumor specific immunity
Time frame: 90 days
Anti-Tumor Response
Determine by radiological, pathological, immunological and by tumor markers any evidence of anti-tumor immune-mediated response.
Time frame: 90 days
This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Mirror Biologics, Inc.