Actively Recruiting
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Led by Eureka Therapeutics Inc. · Updated on 2025-04-09
15
Participants Needed
2
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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, HCN-NOS, or hepatocellular carcinoma with serum AFP >100 ng/mL at screening and after the most recent therapy
- Disease relapse after remission following initial standard care or failure to respond to standard treatment
- Age between 1 and 21 years
- Carry 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: at least one lesion ≥5 mm or two or more lesions ≥3 mm; for dose-expansion: measurable disease by RECIST 1.1
- Child-Pugh score of A6 or better
- Adequate organ function
You will not qualify if you...
- Recurrent hepatoblastoma that can be completely removed by surgery
- Pre-existing conditions such as heart failure, uncontrolled non-cancer lung disease, or psychiatric/social issues limiting study compliance
- Active uncontrolled systemic bacterial, fungal, or viral infection (HIV, hepatitis B or C allowed if treated and controlled)
- Any other active malignancy besides hepatoblastoma, HCN-NOS, or hepatocellular carcinoma
- Pregnant or breastfeeding females
- Recent cytotoxic chemotherapy, radiation, immunotherapy, immunosuppressive therapy, or high-dose corticosteroids within 2 weeks before leukapheresis or conditioning
- Concurrent use of other investigational treatments
- Contraindications to conditioning chemotherapy agents like Fludarabine and Cyclophosphamide
- Active autoimmune disease requiring systemic immunosuppression
- Blood flow problems in the main portal vein, hepatic vein, or vena cava considered unsuitable by the investigator
- History of organ transplant
- Liver involvement greater than 50% by tumor volume
AI-Screening
AI-Powered Screening
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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
CONTACT
P
Pei Wang, PhD
CONTACT
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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