RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2022-07-19

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04634357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \>100ng/mL at the time of screening and following the most recent line of therapy. 2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory). 3. Age ≥ 1 year and ≤ 21 years. 4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele. 5. Life expectancy of \> 4 months per the Investigator's opinion. 6. Lansky or Karnofsky Performance Scale ≥ 70. 7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 8. Child-Pugh score of A6 or better. 9. Adequate organ function.	1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy). 2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would limit compliance with study requirements. 3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled. 4. Any known active malignancy (other than HB, HCN-NOS, or HCC). 5. Pregnant or lactating women. 6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg/day of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed). 7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study. 8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide. 9. Active autoimmune disease requiring systemic immunosuppressive therapy. 10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study. 11. History of organ transplant. 12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).

Inclusion Criteria

Exclusion Criteria

1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \>100ng/mL at the time of screening and following the most recent line of therapy.
2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).
3. Age ≥ 1 year and ≤ 21 years.
4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
5. Life expectancy of \> 4 months per the Investigator's opinion.
6. Lansky or Karnofsky Performance Scale ≥ 70.
7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
8. Child-Pugh score of A6 or better.
9. Adequate organ function.

1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would limit compliance with study requirements.
3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
4. Any known active malignancy (other than HB, HCN-NOS, or HCC).
5. Pregnant or lactating women.
6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg/day of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed).
7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.
9. Active autoimmune disease requiring systemic immunosuppressive therapy.
10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.
11. History of organ transplant.
12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).

Contacts and Locations

Study Contact

Teresa Klask, BS

CONTACT

510-722-8719

Teresa.Klask@eurekainc.com

Pei Wang, PhD

CONTACT

510-654-7045

Pei.Wang@eurekainc.com

Principal Investigator

Pei Wang, PhD

STUDY_DIRECTOR

Eureka Therapeutics Inc.

Study Locations (Sites)

UCSF Benioff Children's Hospitals

San Francisco, California, 94158

United States

Dana-Farber/Boston Children's Cancer and Blood Disorders Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Eureka Therapeutics Inc.

Pei Wang, PhD, STUDY_DIRECTOR, Eureka Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2022-07-19

Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Hepatoblastoma
Hepatocellular Carcinoma (HCC)
Liver Neoplasms
Metastatic Liver Cancer
Liver Cancer
HEMNOS