Summary

Eligibility
for people ages 1-21 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Arun Rangaswami, MD
Headshot of Arun Rangaswami
Arun Rangaswami

Description

Summary

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.

Official Title

An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)

Details

The trial starts with a dose escalation phase. A traditional dose escalation model (3+3) design will be used to determine the recommended phase II dose (RP2D). Subjects will then be treated at the RP2D in the expansion phase of the trial.

Following treatment, tumor response assessments will be performed at Months 1, 3, 6, 9, 12, 18, and 24. At each tumor response assessment visit, imaging will be performed (triphasic CT Scan) and used for response evaluation. Serum AFP levels will also be measured at each tumor response assessment visit.

The active assessment phase of the study will continue for 2 years. Subjects will be followed for 15 years post-treatment for assessment of treatment safety and overall survival.

Keywords

Hepatoblastoma, Hepatocellular Carcinoma (HCC), Liver Neoplasms, Metastatic Liver Cancer, Liver Cancer, HEMNOS, Relapsed/Refractory Hepatoblastoma (HB), Pediatric, Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), T-cell therapy, Carcinoma, Neoplasms, Hepatocellular Carcinoma, ET140203 T Cells

Eligibility

Locations

  • UCSF Benioff Children's Hospitals accepting new patients
    San Francisco California 94158 United States
  • Dana-Farber/Boston Children's Cancer and Blood Disorders Center accepting new patients
    Boston Massachusetts 02215 United States

Lead Scientist at UCSF

  • Arun Rangaswami, MD
    I am one of the senior solid tumor faculty at UCSF, having joined the institution in 2019. My scholarly and clinical practice have focused on the treatment of pediatric liver cancers and rare cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eureka Therapeutics Inc.
ID
NCT04634357
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated