Clinical trial · Interventional
Glypican 3-specific Chimeric Antigen Receptor Expressing T Cells for Hepatocellular Carcinoma (GLYCAR)
Glypican 3-specific Chimeric Antigen Receptor Expressing T Cells As Immunotherapy for Patients with Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study enrolls patients who have a type of cancer that arises from the liver called hepatocellular carcinoma. The cancer has come back, has not gone away after standard treatment, has spread outside of the liver or the patient cannot receive standard treatment. This research study uses special immune system cells called GLYCAR T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. In preclinical studies, the investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33 that recognizes glypican-3, a protein found on almost all hepatocellular carcinoma cells (GPC3-CAR). This study will test T cells genetically engineered with a GPC3-CAR (GLYCAR T cells) in patients with hepatocellular carcinoma. The GLYCAR T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of GLYCAR T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the GLYCAR T cells will help people with GPC3-positive hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoxan | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| GLYCAR T cells | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GLYCAR T cells + Fludarabine and Cytoxan
- description
- GPC3-CAR (GLYCAR T cells) along with lymphodepleting chemotherapy (Cytoxan and Fludarabine) will be administered to patients with hepatocellular carcinoma.
- interventionNames
- Genetic: GLYCAR T cells
- Drug: Cytoxan
- Drug: Fludarabine
Primary outcomes (2)
- measure
- Number of Patients with Dose Limiting Toxicity
- timeFrame
- 6 weeks
- description
- DLT will be defined as any of the following that may, after consultation with the FDA, be considered possibly, probably, or definitely related to the study cellular products. * Any Grade 5 event * Non-hematologic dose-limiting toxicity is any Grade 3 or Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours * Grade 2 to 4 allergic reaction to CAR T cell infusion. * Hematologic dose limiting toxicity is defined as any Grade 4 hematologic toxicity that fails to return to Grade 2 or baseline (whichever is more severe) within 14 days. * Grade 3 and 4 expected reactions due to CRS and neurotoxicity are seen with the use of CAR-based immunotherapy. Grade 3 cytokine release syndrome (CRS) infusion reactions and neurologic toxicity will only be reported to the FDA if they fail to return to Grade 1 within 7 days. Grade 4 CRS and neurologic toxicities will be reported to the FDA in an expedited fashion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Procurement Eligibility Inclusion Criteria: * Histology-proven hepatocellular carcinoma (HCC) which is unresectable, recurrent and/or metastatic * Barcelona Clinic Liver Cancer Stage A, B or C * GPC3-positive HCC * Age ≥ 18 years * Karnofsky score ≥ 60% (See appendix I) * Life expectancy ≥ 12 weeks * Child-Pugh-Turcotte score \<8 * 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 liver transplantation * Known HIV positivity * Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * Severe previous toxicity from cyclophosphamide or fludarabine Treatment Eligibility Inclusion Criteria: * Histology-proven hepatocellular carcinoma (HCC) which is unresectable, recurrent and/or metastatic * Barcelona Clinic Liver Cancer Stage A, B or C * GPC3-positive HCC * Age ≥ 18 years * Life expectancy of ≥ 12 weeks * Karnofsky score ≥ 60% * Child-Pugh-Turcotte score \< 8 * Adequate organ function: * creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 ml/min * serum AST\< 5 times ULN * total bilirubin \< 3 times ULN for age * INR ≤1.7 * absolute neutrophil count \> 500/microliter * platelet count \> 20,000/microliter (can be transfused) * Hgb ≥7.0 g/dl (can be transfused) * Pulse oximetry \>90% on room air * Recovered from acute toxic effects of all prior antineoplastic drugs before entering this study (including investigational drugs) based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, patient is eligible if meeting other eligibility criteria). * Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion. * Available autologous transduced T cell product * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Exclusion Criteria: * Eligible for complete tumor resection or liver transplantation. * Pregnancy or lactation (for women at child-bearing age, birth control is required) * Hepatic encephalopathy * Uncontrolled infection * Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) * Known HIV positivity * Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * History of liver transplantation * Heart failure of Class III-IV and / or C-D per NYHA 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) * Severe previous toxicity from cyclophosphamide or fludarabine
References
Publications (0)
Data not yet available