ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Eureka Therapeutics Inc.
- Study ID
- NCT04634357
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- HEMNOS
- Hepatoblastoma
- Hepatocellular Carcinoma (HCC)
- Liver Cancer
- Liver Neoplasms
- Metastatic Liver Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- ET140203 T Cells — DRUGBiological/Vaccine: ET140203 autologous T-cell product Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
Study Details
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.
Key Dates
- Start date
- Jul 19, 2022
- Status verified
- Apr 2025
- Primary completion
- Jan 31, 2026
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ET140203 T CellsET140203 Autologous T Cells
Primary Outcome Measure
Incidence rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
Central Contacts
- Teresa Klask, MBA510-722-8719
- Pei Wang, PhD510-654-7045
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Benioff Children's Hospitals | San Francisco | California | 94158 | Arun Rangaswami, MD (PRINCIPAL_INVESTIGATOR) |
| Dana-Farber/Boston Children's Cancer and Blood Disorders Center | Boston | Massachusetts | 02215 | Allison O'Neill, MD (PRINCIPAL_INVESTIGATOR) |
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