Liver Cancer Clinical Trial
— ARYA-2Official title:
An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)
Open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety/tolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory HB, HCN-NOS, or HCC.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | January 31, 2028 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber/Boston Children's Cancer and Blood Disorders Center | Boston | Massachusetts |
United States | UCSF Benioff Children's Hospitals | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Eureka Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rates of adverse events (AEs) after infusion of ET140203 T cells | Safety of ET140203 T cells as assessed by the number of adverse events (AEs) after infusion | 28 days | |
Primary | Severity rates of adverse events (AEs) after infusion of ET140203 T cells | Safety of ET140203 T cells as assessed by the severity of adverse events (AEs) after infusion. | 28 days | |
Primary | Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells | Tolerability of ET140203 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs) | 28 days | |
Primary | The recommended phase 2 dose (RP2D) regimen of ET140203 T cell therapy primarily based on DLT | The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLTs. | Up to 2 years | |
Secondary | Assess the efficacy of ET140203 T cells in pediatric subjects with relapsed/refractory HB, HCN-NOS, or HCC | Response rate will be assessed by radiographic scans and assessed according to RECIST criteria. | Up to 2 years | |
Secondary | Determine the pharmacokinetics of ET140203 T cells after infusion. | Assess the expansion and persistence of ET140203 T cells circulating in blood over time. | Up to 2 years |
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