RecruitingHepatoblastomaHepatocellular Carcinoma (HCC)Liver Neoplasms
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Eligible age
1–21 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Eureka Therapeutics Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
San Francisco
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT04634357 · last updated 2025-04-09