Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors

Launched by BAYLOR COLLEGE OF MEDICINE · May 4, 2020

Keywords

ClinConnect Summary

This clinical trial is testing a new experimental treatment using specially modified immune cells called AGAR T cells to fight certain types of pediatric cancers, including liver cancer and other solid tumors. The goal is to see if these engineered T cells, which have been designed to better recognize and attack cancer cells, can help patients whose cancer has come back or who cannot receive standard treatments. The study aims to find the safest dose of these T cells, understand how long they stay active in the body, and identify any side effects.

To be eligible for this trial, patients must be between 1 and 21 years old and have a specific type of cancer that tests positive for a protein called GPC3. They also need to have a life expectancy of at least 16 weeks and be healthy enough to tolerate the treatment. Participants will receive the AGAR T cells through an infusion and will be closely monitored for any side effects. It's important to note that these T cells are not yet approved for general use, and the trial is still in the early stages of testing. If you're considering participation, ensure you discuss it thoroughly with your healthcare team to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• • Procurement Eligibility
• Inclusion Criteria:
• • Diagnosis of GPC3-positive\* solid tumors (as determined by immunohistochemistry with an extent score of \>=Grade 2 \[\>25% positive tumor cells\] and an intensity score of \>= 2 \[scale 0-4\]).
• • Age ≥ 1 year and ≤ 21 years
• • Life expectancy of ≥ 16 weeks
• • Lansky or Karnofsky score ≥60%
• • Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only
• • Child-Pugh-Turcotte score \<7 (for patients with hepatocellular carcinoma only)
• • Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
• Exclusion Criteria:
• • History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
• • History of organ transplantation
• • Known HIV positivity
• • Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
• • Treatment Eligibility
• Inclusion Criteria:
• • Age ≥ 1 year and ≤ 21 years
• • Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
• • Lansky or Karnofsky score ≥ 60%
• • Child-Pugh-Turcotte score \< 7 (for patients with hepatocellular carcinoma only)
• * Adequate organ function:
• • Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
• • serum AST\< 5 times ULN
• • total bilirubin \< 3 times ULN for age
• • INR ≤1.7 (for patients with hepatocellular carcinoma only)
• • absolute neutrophil count \> 500/microliter
• • platelet count \> 25,000/microliter (can be transfused but must be at that level prior to treatment)
• • Hgb ≥7.0 g/dl (can be transfused but must be at that level prior to treatment)
• • pulse oximetry \>90% on room air
• • Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
• • Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
• • Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
• • Informed consent explained to, understood by and signed by patient/ guardian. Patient/guardian given copy of informed consent
• • Exclusion Criteria
• • Pregnancy or lactation
• • Uncontrolled infection
• • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24 hours prior to CAR T cell infusion)
• • Known HIV positivity
• • Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
• • History of organ transplantation
• • History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)