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Immunotherapy for GPC3-Positive Solid Tumors

This study is testing a new way to fight certain cancers like hepatoblastoma and hepatocellular carcinoma using your own immune cells. Researchers will take your T cells (special infection-fighting blood cells) and modify them in the lab to create "21.15.GPC3-CAR T cells." These modified cells are designed to better recognize and kill cancer cells that have a specific marker called GPC3. Before you receive these cells, you will get chemotherapy to prepare your body. The study will look at different doses of these cells to find the safest and most effective amount. To join, you must be 21 years or older, have a GPC3-positive solid tumor, and meet other health criteria. The main goal is to see how many patients experience serious side effects within 4 weeks.

Study design
This is an interventional study with a planned enrollment of 21 participants. It will evaluate three different dosing schedules of the 21.15.GPC3-CAR T cells.
What's involved
You will have blood collected to grow T cells, receive chemotherapy for 3 days, and then get the T-cell infusion over 5 to 10 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety is measured at 4 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06198296

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells

Recruiting
PHASE1Up to 21InterventionalTreatment
Baylor College of Medicine
~21 participants
Updated 2025-11-03 on ClinicalTrials.gov
What's tested:21.15.GPC3-CAR T cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Dose Limiting Toxicity
Measured over 4 weeks

Conditions

Hepatoblastoma
Hepatocellular Carcinoma
Wilms Tumor
Malignant Rhabdoid Tumor
Yolk Sac Tumor
Rhabdomyosarcoma
Liposarcoma
Embryonal Sarcoma of Liver

Explore related trials

HepatoblastomaHepatocellular CarcinomaLiposarcomaLiver Embryonal SarcomaRhabdoid TumorRhabdomyosarcomaSolid NeoplasmWilms TumorYolk Sac TumorGlypican-3

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Premal Lulla, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • David Steffin, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Premal Lulla, MD
[email protected]
(713) 441-1450
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 ≥21 years
Lansky or Karnofsky score ≥60%
Life expectancy ≥16 weeks
Barcelona Clinic Liver Cancer Stage A, B or C (- 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 \* GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Texas Patients's Hospital/Baylor College of Medicine, Department of Pathology for all patients to meet procurement eligibility. All patients will send at least 5 unstained slides.
Diagnosis of GPC3-positive solid tumor
Age ≥ 21 years
Barcelona Clinic Liver Cancer Stage A, B or C
Life expectancy of ≥ 12 weeks
Lansky or Karnofsky score ≥ 60%
Child-Pugh-Turcotte score \< 7
Adequate organ function:
Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
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, as determined by history and physical exam
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

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)
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 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)

What this trial measures

  • Number of Patients with Dose Limiting Toxicity4 weeks

    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; Hematologic Grade 4 that fails to return to Grade 2 or baseline (whichever is more severe) within 14 days; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days