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

Last updated: April 7, 2025
Sponsor: Eureka Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Liver Cancer

Neoplasms

Digestive System Neoplasms

Treatment

ET140203 T Cells

Clinical Study ID

NCT04634357
ETUS20AFPAR123
  • Ages 1-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP >100ng/mL at the time ofscreening 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 subjectcarries 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 thedose-expansion cohort, subjects must have measurable disease by Response EvaluationCriteria in Solid Tumors (RECIST) version 1.1.

  8. Child-Pugh score of A6 or better.

  9. Adequate organ function.

Exclusion

Exclusion Criteria:

  1. Recurrent HB who are candidates for complete surgical resection (e.g., isolatedpulmonary relapse amendable to pulmonary metastasectomy).

  2. Pre-existing illness including heart failure, uncontrolled pulmonary disease notcancer-related, or psychiatric illness/social situation that would limit compliancewith study requirements.

  3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects withHuman Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligibleprovided 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) weeksof conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancertherapies (including immunotherapeutic agents), immunosuppressive therapy, orsystemic corticosteroids at doses greater than 5 mg/day of prednisone or equivalentdoses of other corticosteroids. (Note: Topical and inhaled corticosteroids instandard doses and physiological replacement doses of corticosteroids for adrenalinsufficiency are allowed).

  7. Concurrently receiving other investigational agents, biological, chemical, orradiation therapies, while participating in the study.

  8. Contraindication for receipt of conditioning chemotherapeutic agents includingFludarabine and Cyclophosphamide.

  9. Active autoimmune disease requiring systemic immunosuppressive therapy.

  10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due topartial or complete obstruction which, in the opinion of the Investigator, wouldmake 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).

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: ET140203 T Cells
Phase: 1/2
Study Start date:
July 19, 2022
Estimated Completion Date:
January 31, 2028

Study Description

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.

Connect with a study center

  • UCSF Benioff Children's Hospitals

    San Francisco, California 94158
    United States

    Active - Recruiting

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

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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