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 — DRUG
    Biological/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 Cells
    ET140203 Autologous T Cells

Primary Outcome Measure

Incidence rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalsSan FranciscoCalifornia94158
Karina Wong, CCRP
415-298-9434
Arun Rangaswami, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Boston Children's Cancer and Blood Disorders CenterBostonMassachusetts02215
Jill MacDonald
617-632-4930
Allison O'Neill, MD (PRINCIPAL_INVESTIGATOR)

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