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ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (ARYA-2)

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ClinicalTrials.gov Identifier: NCT04634357
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Eureka Therapeutics Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hepatoblastoma Hepatocellular Carcinoma (HCC) Liver Neoplasms Metastatic Liver Cancer Liver Cancer HEMNOS Drug: ET140203 T Cells Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 19, 2022
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ET140203 T Cells
ET140203 Autologous T Cells
 Drug: ET140203 T Cells

Biological/Vaccine: ET140203 autologous T-cell product

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Safety of ET140203 T cells as assessed by the number of adverse events (AEs) after infusion

  2. Severity rates of adverse events (AEs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Safety of ET140203 T cells as assessed by the severity of adverse events (AEs) after infusion.

  3. Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells [ Time Frame: 28 days ]
    Tolerability of ET140203 T cells after infusions assessed by committee review of dose limiting toxicities (DLTs)

  4. The recommended phase 2 dose (RP2D) regimen of ET140203 T cell therapy primarily based on DLT [ Time Frame: Up to 2 years ]
    The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLTs.


Secondary Outcome Measures :
  1. Assess the efficacy of ET140203 T cells in pediatric subjects with relapsed/refractory HB, HCN-NOS, or HCC [ Time Frame: Up to 2 years ]
    Response rate will be assessed by radiographic scans and assessed according to RECIST criteria.

  2. Determine the pharmacokinetics of ET140203 T cells after infusion. [ Time Frame: Up to 2 years ]
    Assess the expansion and persistence of ET140203 T cells circulating in blood over time.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Exclusion Criteria:

  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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634357


Contacts
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Contact: Teresa Klask, BS 510-722-8719 ext 412 Teresa.Klask@eurekainc.com
Contact: Pei Wang, PhD 510-654-7045 Pei.Wang@eurekainc.com

Locations
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United States, California
UCSF Benioff Children's Hospitals Recruiting
San Francisco, California, United States, 94158
Contact: Karina Wong, CCRP    415-298-9434    karina.wong@ucsf.edu   
Principal Investigator: Arun Rangaswami, MD         
United States, Massachusetts
Dana-Farber/Boston Children's Cancer and Blood Disorders Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jill MacDonald    617-632-4930    Jill_Macdonald@DFCI.Harvard.edu   
Principal Investigator: Allison O'Neill, MD         
Sponsors and Collaborators
Eureka Therapeutics Inc.
Investigators
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Study Director: Pei Wang, PhD Eureka Therapeutics Inc.
More Information
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Responsible Party: Eureka Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04634357    
Other Study ID Numbers: ETUS20AFPAR123
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eureka Therapeutics Inc.:
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:
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Carcinoma
Neoplasms
Carcinoma, Hepatocellular
Liver Neoplasms
Hepatoblastoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed