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

Launched by BAYLOR COLLEGE OF MEDICINE · Oct 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for certain types of solid tumors, specifically those that test positive for a protein called GPC3, which is often found in liver cancer and other cancers like Wilms tumor and rhabdomyosarcoma. The treatment uses specially modified immune cells known as CATCH T cells, which are designed to better recognize and attack cancer cells. Researchers hope this combination of T cells and an added gene can enhance the immune response against the tumors. Participants in this trial may be individuals whose cancer has returned or who did not respond to standard treatments, and who are at least 18 years old and meet specific health criteria.

If you join the trial, you can expect to receive these engineered T cells and be monitored closely for how well they work and any side effects. The goal is to determine the safest dose of the treatment and how long the T cells remain active in the body. Importantly, this is an experimental treatment that has not yet been approved for general use, so participation is entirely voluntary and requires informed consent, meaning you’ll need to understand and agree to the details of the study before participating.

Gender

ALL

Eligibility criteria

• • Procurement Eligibility
• Inclusion Criteria:
• • Relapsed or refractory 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 ≥18 years
• • Lansky or Karnofsky score ≥60%
• • Life expectancy ≥16 weeks
• • 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 ≥ 18 years
• • Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
• • Life expectancy of ≥ 12 weeks
• • 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/μl
• • platelet count \> 25,000/μl (can be transfused)
• • Hgb ≥ 7.0 g/dl (can be transfused)
• • 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 (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs 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)