ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (NCT04634357) | Clinical Trial Compass
RecruitingPhase 1/2
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
United States15 participantsStarted 2022-07-19
Plain-language summary
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.
Who can participate
Age range1 Year – 21 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).
✓. Age ≥ 1 year and ≤ 21 years.
✓. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
✓. Life expectancy of \> 4 months per the Investigator's opinion.
✓. Lansky or Karnofsky Performance Scale ≥ 70.
✓. 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.
✓. Child-Pugh score of A6 or better.
Exclusion criteria
✕. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
✕. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would limit compliance with study requirements.
✕
What they're measuring
1
Incidence rates of adverse events (AEs) after infusion of ET140203 T cells
Timeframe: 28 days
2
Severity rates of adverse events (AEs) after infusion of ET140203 T cells
Timeframe: 28 days
3
Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells
Timeframe: 28 days
4
The recommended phase 2 dose (RP2D) regimen of ET140203 T cell therapy primarily based on DLT
. 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.
✕. Any known active malignancy (other than HB, HCN-NOS, or HCC).
✕. Pregnant or lactating women.
✕. 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).
✕. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
✕. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.