- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634357
ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma (ARYA-2)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Teresa Klask, BS
- Phone Number: 412 510-722-8719
- Email: Teresa.Klask@eurekainc.com
Study Contact Backup
- Name: Pei Wang, PhD
- Phone Number: 510-654-7045
- Email: pei.wang@eurekainc.com
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- UCSF Benioff Children's Hospitals
-
Principal Investigator:
- Arun Rangaswami, MD
-
Contact:
- Karina Wong, CCRP
- Phone Number: 415-298-9434
- Email: karina.wong@ucsf.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center
-
Principal Investigator:
- Allison O'Neill, MD
-
Contact:
- Jill MacDonald
- Phone Number: 617-632-4930
- Email: Jill_Macdonald@DFCI.Harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).
- Age ≥ 1 year and ≤ 21 years.
- Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
- Life expectancy of > 4 months per the Investigator's opinion.
- Lansky or Karnofsky Performance Scale ≥ 70.
- 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.
- Child-Pugh score of A6 or better.
- Adequate organ function.
Exclusion Criteria:
- Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
- Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would limit compliance with study requirements.
- 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.
- Any known active malignancy (other than HB, HCN-NOS, or HCC).
- Pregnant or lactating women.
- 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).
- Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
- Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- 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.
- History of organ transplant.
- HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ET140203 T Cells
ET140203 Autologous T Cells
|
Biological/Vaccine: ET140203 autologous T-cell product Autologous T cells transduced with lentivirus encoding an ET140203 expression construct |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
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.
|
28 days
|
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)
|
28 days
|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
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.
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pei Wang, PhD, Eureka Therapeutics Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETUS20AFPAR123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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