ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma

Launched by EUREKA THERAPEUTICS INC. · Nov 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using ET140203 T-cells for children and young adults with certain types of liver cancer, including hepatoblastoma and hepatocellular carcinoma. The goal is to see if this treatment is safe and to find the right dosage to use in future studies. The trial is currently looking for participants aged 1 to 21 who have had these cancers return after treatment or who did not respond well to standard therapies. To qualify, participants need to have a specific protein in their blood and a particular genetic marker, among other health criteria.

If a patient joins the trial, they can expect to receive the ET140203 T-cells after undergoing a procedure to collect their own immune cells. They will be monitored closely throughout the study to ensure their safety and to gather information about how well the treatment is working. It's important to note that there are specific health conditions that could prevent someone from participating, such as having other active cancers or serious infections. Overall, this trial represents an exciting opportunity for young patients with liver cancer to receive a potentially new and personalized treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \>100ng/mL at the time of screening and following the most recent line of therapy.
• • 2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).
• • 3. Age ≥ 1 year and ≤ 21 years.
• • 4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
• • 5. Life expectancy of \> 4 months per the Investigator's opinion.
• • 6. Lansky or Karnofsky Performance Scale ≥ 70.
• • 7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• • 8. Child-Pugh score of A6 or better.
• • 9. Adequate organ function.
• Exclusion Criteria:
• • 1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
• • 2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would limit compliance with study requirements.
• • 3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
• • 4. Any known active malignancy (other than HB, HCN-NOS, or HCC).
• • 5. Pregnant or lactating women.
• • 6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg/day of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed).
• • 7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
• • 8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.
• • 9. Active autoimmune disease requiring systemic immunosuppressive therapy.
• • 10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.
• • 11. History of organ transplant.
• • 12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).