ET140203 T Cells for treating pediatric liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is an open-label, dose escalation study designed to evaluate the safety and tolerability of ET140203 T-cells in pediatric patients with relapsed or refractory hepatoblastoma, hepatocellular neoplasm-not otherwise specified, or hepatocellular carcinoma. The trial will begin with a dose escalation phase using a traditional 3+3 design to determine the recommended Phase II dose. Following this, subjects will receive treatment at the recommended dose, with tumor response assessments conducted at regular intervals over a two-year period. Participants will be monitored for safety and overall survival for up to 15 years post-treatment.

Why it matters

Who can join: the full rules

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 recurrence 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 one (1) week of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), or immunosuppressive therapy. Systemic corticosteroids at doses greater than 5 mg/day of prednisone or equivalent doses of other corticosteroids within two (2) weeks prior to leukapheresis or conditioning chemotherapy or receipt of a T-cell engager (TCE) within two (2) months prior to leukapheresis or at any time as bridging therapy between leukapheresis and conditioning chemotherapy is exclusionary. (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).

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Children's Hospital Orange County
  Orange, California, United States Recruiting
• UCSF Benioff Children's Hospitals
  San Francisco, California, United States Recruiting
• Dana-Farber/Boston Children's Cancer and Blood Disorders Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Teresa Klask, MBA
• Email: Teresa.Klask@eurekainc.com
• Phone: 510-722-8719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.