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SC-CAR.GPC3xIL15.21 CAR T-cells for GPC3-Positive Solid Tumors

This study is testing a new treatment called SC-CAR.GPC3xIL15.21 CAR T cells for adults with certain solid tumors that have come back or are hard to treat. These CAR T cells are made from your own immune cells and are designed to find and kill cancer cells that have a specific marker called GPC3. The study will look at how safe this treatment is and if it helps shrink tumors. To join, you must be an adult with a GPC3-positive solid tumor (excluding brain tumors), have a good performance status, and a life expectancy of more than 16 weeks. For those with hepatocellular carcinoma (a type of liver cancer), specific liver cancer stages are also required. The study aims to enroll 21 participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know what treatment you are receiving. It is not randomized and plans to enroll 21 adult participants.
What's involved
You will have a blood sample collected to create the CAR T cells. You will receive an intravenous infusion of SC-CAR.GPC3xIL15.21 T cells after chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the safety of the treatment for 42 days after the infusion.

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

NCT07224568

Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors

Not Yet Recruiting
PHASE1Ages 21+InterventionalTreatment
Seattle Children's Hospital
~21 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:SC-CAR.GPC3xIL15.21 CAR T cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed
Measured over 28 days
+1 more outcome measured

Conditions

Solid Tumor (Excluding CNS)
Hepatocellular Carcinoma
Liver Cell Carcinoma
Liposarcoma
Yolk Sac Tumor
Rhabdomyosarcoma

Explore related trials

Hepatocellular CarcinomaLiposarcomaRhabdomyosarcomaSolid NeoplasmYolk Sac TumorGlypican-3

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Colleen Annesley · STUDY_DIRECTOR · Seattle Children's Hospital
  • Corinne Summers · STUDY_DIRECTOR · Seattle Children's Hospital

Who to contact

Gentry King, MD
[email protected]; [email protected]
206-606-1024
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of a solid tumor expressing GPC3
Karnofsky score of \>=60%
Life expectancy of \>16 weeks
Informed consent explained to, understood by and signed by participant or participant's legally authorized representative
Barcelona Liver Cancer Stage A, B or C
Child-Pugh-Turcotte Score \<7
Karnofsky score of \>=60%
Life expectancy of \>16 weeks
Informed consent explained to, understood by and signed by patient/guardian.
Adequate organ function
Adequate laboratory values
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.
Barcelona Liver Cancer Stage A, B or C
Child-Pugh Turcotte Score \<7

Exclusion

History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for 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) 2. Treatment eligibility
History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for 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
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)

What this trial measures

  • The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed28 days

    The proportion of SC-CAR.GPC3xIL15.21 T cell products that are approved for release after up to 2 grow attempts will be measured.

  • To determine the safety of escalating doses of an intravenous injection of SC-CAR.GPC3xIL15.21 T cells in adults with relapsed or refractory GPC3-positive solid tumors after lymphodepleting chemotherapy based on frequency of adverse events based on CTCAE42 days

    The type, frequency, severity, and duration of adverse events will be tabulated and summarized