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CARE T cells for Pediatric Solid Tumors

This study is testing a new experimental treatment called CARE T cells for children and young adults (ages 1 to 21) with certain solid tumors, including liver cancer and rhabdomyosarcoma. You might be able to join if your cancer has returned, hasn't responded to standard treatments, or you can't receive standard treatment. The CARE T cells are special immune cells that are genetically engineered to find and fight cancer cells that have a specific marker called GPC3. Before receiving the CARE T cells, you will get chemotherapy (cyclophosphamide and fludarabine) to prepare your body. The main goal of this study is to see how safe CARE T cells are at different doses. We are looking for about 24 participants.

Study design
This is an interventional study planning to enroll about 24 participants. It will evaluate four different dosing schedules of CARE T cells.
What's involved
You will have blood drawn to create the CARE T cells. You will receive lymphodepletion chemotherapy for 3 days before getting the CARE T cell infusion, which takes 5 to 10 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures dose-limiting toxicity 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.

NCT04715191

Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors

Recruiting
PHASE1Ages 1–21InterventionalTreatment
Baylor College of Medicine
~24 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:CARE 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

Liver Cancer
Rhabdomyosarcoma
Malignant Rhabdoid Tumor
Liposarcoma
Wilms Tumor
Yolk Sac Tumor

Explore related trials

LiposarcomaLiver CarcinomaRhabdoid TumorRhabdomyosarcomaSolid NeoplasmWilms TumorYolk Sac TumorGlypican-3

Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

David Steffin
[email protected]
(832) 824-4233
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 ≥1 year and ≤ 21 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
Age ≥ 1 year and ≤ 21 years
Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
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
Total bilirubin \< 3 times ULN for age
INR ≤1.7 (for patients with hepatocellular carcinoma only)
Absolute neutrophil count \> 750/µl
Platelet count \> 75,000/µl (Needs to be confirmed prior to treatment whether with or without transfusion)
Hgb ≥ 8.0 g/dl (Needs to be confirmed prior to treatment whether with or without transfusion)
Pulse oximetry ≥ 92% on room air
Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy)
Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, as determined by history and physical exam.
Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 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 24 hours prior to CAR T cell infusion)
Known HIV positivity
Active bacterial, fungal or viral infection \[except Hepatitis B (HBV patients with active disease who meet the criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy) or Hepatitis C virus infections (should have completed curative antiviral treatment with HCV viral load below the limit of quantification\]
Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis
Active autoimmune or inflammatory disorder
Live vaccines within 30 days prior to enrollment
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 7 days 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.