ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eureka Therapeutics Inc.

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).