NCT02932956Active, not recruitingPhase 1
Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)
Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells as Immunotherapy for Patients With Pediatric Solid Tumors
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
This study enrolls patients who have GPC3-positive solid tumors currently. Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called GAP 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 proteoglycan found on solid tumors including pediatric liver cancers (GPC3-CAR). This study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in patients with GPC3-positive solid tumors (currently only enrolling liver tumors). The GAP 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 GAP 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 GAP T cells will help people with GPC3-positive solid tumors. This study enrolls patients who have GPC3-positive solid tumors (currently only enrolling liver tumors).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 12 Oct 2016
- Start date
- 17 Dec 2018
- Primary completion date
- 27 Sept 2021
- Lead sponsor
- Baylor College of Medicine
- NCT number
- NCT02932956
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 17 Dec 2018 to the primary completion date, 27 Sept 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Treatment Eligibility
- 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)
- 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
- GPC3 expression will be evaluated by standard immunohistochemistry (IHC). A tumor is considered GPC3 positive, when the staining is Grade 2 (\>25% positive tumor cells) or above with an intensity score of 2 or above on a scale of 0 to 4.
Other illness
- History of organ transplantation
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
- Uncontrolled infection
- Known HIV positivity
- Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
- History of organ transplantation
Other
- Pregnancy or lactation
Who the study is looking for
- Relapsed or refractory GPC3-positive\* solid tumors (currently only enrolling liver tumors)
- Age ≥ 1 year and ≤ 21 years
- Lansky or Karnofsky score ≥60%
- Life expectancy ≥16 weeks
- 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
- Age ≥ 1 year and ≤ 21 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/microliter
- platelet count \> 25,000/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 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
Criteria the registry did not label
- Procurement Eligibility
Age in the registry: 1 year to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.