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.
Title
- Brief Title: ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
- 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)
Clinical Trial IDs
- ORG STUDY ID:
ETUS20AFPAR123
- NCT ID:
NCT04634357
Conditions
- Hepatoblastoma
- Hepatocellular Carcinoma (HCC)
- Liver Neoplasms
- Metastatic Liver Cancer
- Liver Cancer
- HEMNOS
Interventions
Drug | Synonyms | Arms |
---|
ET140203 T Cells | | ET140203 T Cells |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
ET140203 T Cells | Experimental | ET140203 T Cells | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP >200ng/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 Principal 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 RECIST v1.1.
8. Child-Pugh score of B7 or better.
9. Adequate organ function.
Exclusion Criteria:
1. Received the following within two (2) weeks of leukapheresis and within two (2) weeks
of conditioning chemotherapy: cytotoxic chemotherapy, radiation, systemic
corticosteroids, other anti-cancer therapies (including immunotherapeutic agents), or
any other immunosuppressive agents (Note: use of inhaled or topical steroids is not
exclusionary).
2. Concurrently receiving other investigational agents, biological, chemical, or
radiation therapies, while participating in the study.
3. Contraindication for receipt of conditioning chemotherapeutic agents including
Fludarabine and Cyclophosphamide.
4. Active autoimmune disease requiring systemic immunosuppressive therapy.
5. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to
partial or complete obstruction which, in the opinion of the Principal Investigator,
would make the subject unsuitable for the study.
6. History of organ transplant.
7. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).
Maximum Eligible Age: | 21 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rates of adverse events (AEs) after infusion of ET140203 T cells |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Safety of ET140203 T cells as assessed by the number of adverse events (AEs) after infusion |
Secondary Outcome Measures
Measure: | Assess the efficacy of ET140203 T cells in pediatric subjects with relapsed/refractory HB, HCN-NOS, or HCC |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Response rate will be assessed by radiographic scans and assessed according to RECIST criteria. |
Measure: | Determine the pharmacokinetics of ET140203 T cells after infusion. |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Assess the expansion and persistence of ET140203 T cells circulating in blood over time. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Eureka Therapeutics Inc. |
Trial Keywords
- 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
Last Updated
August 17, 2021