[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

(510) 722-8719

Email address

karen.cravotto@eurekainc.com

Condition

Hepatocellular Carcinoma,Liver Cancer,Liver Neoplasm,Metastatic Liver Cancer

Treatment type

Interventional

Investigational product

ET140203 autologous T cell product

Phase

Phase 1/Phase 2

Sponsor

Eureka Therapeutics Inc.

ClinicalTrials.gov identifier

NCT04502082

Study number

ETUS19AFPAR121

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About the study

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Histologically confirmed HCC with serum AFP >100ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP >400ng/ml at time of screening and following most current line of therapy.
  2. Metastatic or locally advanced, unresectable HCC
  3. Must have failed or not tolerated at least two (2) different anti-HCC systemic agents
  4. Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
  5. Life expectancy of at least 4 months
  6. Karnofsky Performance Scale greater than or equal to 70
  7. At least 1 measurable lesion on imaging by RECIST
  8. Child-Pugh A6 or better
  9. Absolute neutrophil count greater than or equal to 1,500/mm^3
  10. Platelet count greater than or equal to 75,000/mm^3
Exclusion criteria

  1. Clinically significant cardiac disease
  2. Clinically significant pre-existing illness or active infection
  3. Clinically significant Central Nervous System (CNS) or neural dysfunction
  4. Active autoimmune disease requiring therapy
  5. Active malignancy other than HCC with the exception of cholangiocarcinoma (CCA) or any malignancy with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen-deprivation therapy) and without any organ involvement
  6. History of organ transplant
  7. Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
  8. Advanced HCC involving greater than 50% of the liver

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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