Advanced HCC Advanced HCC Immunotherapy
Conditions
Interventions
AlloStim®: AlloStim® is derived from the blood of healthy,
screened donors. Donors are tested for blood borne diseases and for any lifestyle or travel habits which might cause a risk for transmission of disease through the blood. Whole blood is collected from
Stim. To produce T-
Stim,
CD4 cells are purified from the source buffy coat and cultured in bioreactors. The cells expand and differentiate into T-
Stim by adding anti-
CD3/anti-
CD28 coated microbeads every 3 days for 9 days. After a 9-
day culture process,
the purified CD4 cells expand approximately 50-
fold and differentiate from naïve CD4 cells to activated memory cells to become T-
Stim. The intermediate T-
Stim product is debeaded,
washed and aliquoted into storage bags with cryogenic protective media and stored frozen in liquid nitrogen. T-
Stim is stable in liquid nitrogen for at least 5 years. T-
Stim is tested for safety,
identity,
function and ability to differentiate into AlloStim® prior to release. When AlloStim® is required for dosing in clinic,
frozen T-
Stim vials are removed from released frozen inventory,
Sponsors
Dr. Michael Hay-Nor
MIRROR Biologics Inc
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or Female ≥18yo and ≤ 75yo with histologically or radiologically confirmed hepatocellular carcinoma (HCC). 1.1 Non-resectable disease 1.2 not amenable to local therapy with curative intent (surgery, radiation, ablation, TACE) 1.3 With or without positive Hepatitis B Virus HBV and/or Hepatitis C Virus (HCV) 2. BCLC stage C disease with no prior treatment 2.1 Not eligible for, or unable to obtain access to first line: sorafenib or lenvatinib. 2.2 With or without extrahepatic disease 3. Child-Pugh Class A or Class B 3.1 with or without macrovascular invasion (MVI) 4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 4.1 with no deterioration over the previous 2 weeks 5. Measurable enhancing disease in liver (mRECIST) 6. Adequate liver and renal function as assessed by the following: 6.1 Hemoglobin > 10.0 g/dl 6.2 Platelet count > 75,000/μl 6.3 ALT and AST < 5 x ULN 6.4 Alkaline phosphatase < 4 x ULN 6.5 Serum creatinine < 1.5 7. Women of child-bearing potential o negative pregnancy test 7.1 usage of contraception or avoidance of pregnancy measures while enrolled on study 8. Ability to regularly visit the research institutions per protocol for related tests, evaluations, and management during the study period. 9. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate 9.1 Travel stipend allowed
Exclusion criteria
Exclusion criteria: 1.Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma). 2. Prior exposure to checkpoint inhibitors (PD-1/PD-L1 or CTLA4) 3. Enrollment in any previous clinical trial for HCC 4. Received or undergone any prior procedures, medications or treatments for HCC 5. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator) 6. International normalized ratio (INR) >1.7 (+2 or +3 on Child-Pugh calculator) 7. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy 7.1 >grade 1 (+2 or +3 on Child-Pugh calculator) 8. Score of >9 on Child-Pugh calculator (class C) 9. Severe stomach/esophageal varices requiring interventional treatment. 10. Clinically significant gastrointestinal bleeding within 30 days prior to study entry 11. History of Chronic obstructive pulmonary disease (COPD) or oxygen saturation New York Heart Association (NYHA) class 2; cardiac arrhythmias requiring anti-arrhythmic therapy o beta blockers or Digoxin are permitted 18. History of stroke or pulmonary embolism within 1 year of accrual 19. Active clinically serious infections (> grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version 5) 20. History of organ or tissue allograft 21. Uncontrolled concurrent serious medical or psychiatric illness 22. Clinically apparent central nervous system metastases or carcinomatous meningitis 23. History of blood transfusion reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival weekly Survival follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life weekly Questionnnaire | — |
Countries
Thailand
Contacts
Public ContactDr. Krittiya Korphaisarn
Faculty of Medicine, Siriraj Hospital
Outcome results
None listed