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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.

Tracking Information
First Submitted Date  ICMJE November 4, 2020
First Posted Date  ICMJE November 18, 2020
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE July 19, 2022
Estimated Primary Completion Date January 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • 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
  • 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.
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatoblastoma
  • Hepatocellular Carcinoma (HCC)
  • Liver Neoplasms
  • Metastatic Liver Cancer
  • Liver Cancer
  • HEMNOS
Intervention  ICMJE Drug: ET140203 T Cells

Biological/Vaccine: ET140203 autologous T-cell product

Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
Study Arms  ICMJE Experimental: ET140203 T Cells
ET140203 Autologous T Cells
Intervention: Drug: ET140203 T Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2022)		 15
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2020)		 25
Estimated Study Completion Date  ICMJE January 31, 2028
Estimated Primary Completion Date January 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Teresa Klask, BS 510-722-8719 ext 412 Teresa.Klask@eurekainc.com
Contact: Pei Wang, PhD 510-654-7045 Pei.Wang@eurekainc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04634357
Other Study ID Numbers  ICMJE ETUS20AFPAR123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eureka Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eureka Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pei Wang, PhD Eureka Therapeutics Inc.
PRS Account Eureka Therapeutics Inc.
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP