ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eureka Therapeutics Inc.
Study ID
NCT04634357
Phase
PHASE1/PHASE2
Status
Recruiting
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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

First listed
Nov 18, 2020
Start date
Jul 19, 2022
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
12 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 (4)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Silpa Sharma, MPH, CCRC
[email protected]
323-361-6475
Rachana Shah, MD, MS (PRINCIPAL_INVESTIGATOR)
Children's Hospital Orange CountyOrangeCalifornia92868
Dorian Chan
[email protected]
714-509-7868
Rishikesh Chavan, MD (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's HospitalsSan FranciscoCalifornia94158
Brian Luong, CCRP
[email protected]
Arun Rangaswami, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Boston Children's Cancer and Blood Disorders CenterBostonMassachusetts02215
Jill MacDonald
[email protected]
617-632-4930
Allison O'Neill, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Orange County· Orange, CAUCSF Benioff Children's Hospitals· San Francisco, CADana-Farber/Boston Children's Cancer and Blood Disorders Center· Boston, MA

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