Actively Recruiting
An Open-Label, Dose Escalation, Phase I/II Trial of ET140203 T Cells in Pediatric Subjects With Relapsed or Refractory Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Led by Eureka Therapeutics Inc. · Updated on 2025-04-09
15
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ET140203 T cells in pediatric patients aged 1 to 21 years who have relapsed or refractory hepatoblastoma (HB), hepatocellular neoplasm-not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC) that are positive for AFP and carry the HLA-A2 allele. The study is an open-label, dose escalation Phase I/II trial designed to assess the safety and tolerability of these T cells and to find the recommended dose for further study. This trial is conducted by Eureka Therapeutics Inc. across multiple centers. The trial begins with a dose escalation phase using a traditional 3+3 design to establish the recommended Phase II dose (RP2D). After determining the RP2D, subjects enter an expansion phase receiving the ET140203 autologous T-cell therapy at this dose. Treatment involves infusion of T cells transduced with a lentivirus encoding the ET140203 construct. Following treatment, tumor responses are evaluated through imaging and serum AFP measurements at months 1, 3, 6, 9, 12, 18, and 24. Participants will be actively assessed for two years post-treatment, including tumor imaging with triphasic CT scans and AFP blood tests. After this period, they will be followed for up to 15 years to monitor long-term safety and overall survival. The primary outcomes include incidence and severity of adverse events and dose limiting toxicities within 28 days, while secondary outcomes assess efficacy and pharmacokinetics of the ET140203 T cells.
CONDITIONS
Brief Title
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed hepatoblastoma (HB), hepatocellular neoplasm-not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC) with serum AFP >100 ng/mL at screening and after the most recent therapy.
- Disease relapse after remission following initial standard-of-care treatment or failure to respond to such treatment.
- Age 1 year or older and 21 years or younger.
- Presence of at least one HLA-A2 allele confirmed by molecular typing.
- Life expectancy greater than 4 months as judged by the Investigator.
- Lansky or Karnofsky Performance Scale score of 70 or higher.
- For dose-finding cohort, at least one lesion ≥5 mm or two or more lesions ≥3 mm; for dose-expansion cohort, measurable disease by RECIST 1.1.
- Child-Pugh liver function score of A6 or better.
- Adequate organ function as required by the study.
You will not qualify if you...
- Candidates for complete surgical resection of recurrent hepatoblastoma, such as isolated pulmonary relapse amenable to surgery.
- Pre-existing illnesses like heart failure, uncontrolled non-cancer lung disease, or psychiatric/social issues limiting study compliance.
- Active uncontrolled infections (bacterial, fungal, or viral); treated and controlled HIV, hepatitis B, or C are allowed.
- Any active cancer other than HB, HCN-NOS, or HCC.
- Pregnant or breastfeeding women.
- Receipt of cytotoxic chemotherapy, radiation, immunotherapy, immunosuppressive therapy, or high-dose corticosteroids within two weeks before leukapheresis or conditioning chemotherapy.
- Concurrent use of other investigational agents or therapies during the study.
- Contraindications to conditioning chemotherapy agents like Fludarabine and Cyclophosphamide.
- Active autoimmune disease needing systemic immunosuppressive therapy.
- Significant obstruction of major liver blood vessels making participation unsuitable.
- History of organ transplantation.
- Liver involvement greater than 50% by tumor volume.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive ET140203 autologous T cell therapy through a dose escalation phase followed by treatment at the recommended phase II dose.
Visits for infusion and monitoring during dose escalation and expansion phases
Duration - Up to 15 years
Participants undergo tumor response assessments with imaging and serum AFP measurements at Months 1, 3, 6, 9, 12, 18, and 24 after treatment ends. Participants are then followed for safety and overall survival for up to 15 years post-treatment.
Approximately 7 tumor response assessment visits in first 2 years and periodic visits during long-term follow-up
Trial Site Locations
Total: 2 locations
1
UCSF Benioff Children's Hospitals
San Francisco, California, United States, 94158
Actively Recruiting
2
Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
T
Teresa Klask, MBA
P
Pei Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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