Actively Recruiting
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors
Led by Baylor College of Medicine · Updated on 2026-04-06
24
Participants Needed
1
Research Sites
778 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates a new experimental treatment called CARE T cells for children and young adults aged 1 to 21 years with GPC3-positive solid tumors, including certain pediatric liver cancers and other solid tumors that have returned, not responded to standard treatment, or cannot be treated with standard options. The study aims to find the highest safe dose of these genetically engineered T cells, understand how long they persist in the body, identify side effects, and evaluate their potential effectiveness. CARE T cells are designed to target cancer cells by combining antibody and T cell properties enhanced with IL15 and IL21 genes to improve their function and longevity. Participants will have blood collected to grow and genetically modify their T cells using a retrovirus to insert the GPC3-CAR gene along with IL15 and IL21. Before receiving the CARE T cells, patients undergo lymphodepletion chemotherapy with cyclophosphamide and fludarabine for three days to reduce existing T cells and make space for the new ones. The frozen CARE T cells are then thawed and infused intravenously within 48 to 96 hours after chemotherapy. The study uses a dose-escalation design with increasing doses given to groups of participants to determine safety and tolerability. Throughout the study, participants undergo various medical tests including physical exams, blood tests for organ function and tumor markers, and imaging scans to monitor tumor response. Blood samples are collected at multiple time points up to 15 years after infusion to study T cell persistence and activity and to monitor long-term safety. Optional tumor biopsies may be taken to assess the treatment's effect on tumors. The total study participation lasts up to 15 years with regular follow-up visits for health assessments.
CONDITIONS
Brief Title
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of GPC3-positive solid tumors with at least 25% positive tumor cells and intensity score of 2 or higher
- Age between 1 and 21 years
- Lansky or Karnofsky performance score of 60% or higher
- Life expectancy of at least 16 weeks
- For hepatocellular carcinoma patients: Barcelona Clinic Liver Cancer Stage A, B or C
- For hepatocellular carcinoma patients: Child-Pugh-Turcotte score less than 7
- Signed informed consent by patient or guardian
- Adequate organ function including creatinine clearance of at least 60 ml/min, bilirubin less than 3 times upper limit of normal, INR of 1.7 or less (for hepatocellular carcinoma), neutrophil count above 750/µl, platelet count above 75,000/µl, hemoglobin at least 8.0 g/dl, and pulse oximetry of 92% or higher on room air
- Disease not curable by standard therapies and recovered from prior treatment toxicities
- Sexually active patients agree to use effective birth control for 6 months after infusion
You will not qualify if you...
- History of hypersensitivity to murine protein products or presence of human anti-mouse antibody
- History of organ transplantation
- Known HIV infection
- Active bacterial, fungal, or viral infections except controlled Hepatitis B or cured Hepatitis C
- Pregnancy or lactation
- Systemic steroid treatment at or above 0.5 mg/kg/day prednisone equivalent within 24 hours before infusion
- Congestive heart failure NYHA class III or IV, unstable angina, uncontrolled arrhythmia, recent myocardial infarction, or myocarditis
- Active autoimmune or inflammatory disorders
- Live vaccines within 30 days prior to enrollment
- Active uncontrolled infections or immune compromise not meeting criteria for inclusion criteria treatment eligibility conditions
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 3 days
Participants receive chemotherapy with cyclophosphamide and fludarabine for 3 days to reduce their own T cells before the CAR T-cell infusion.
3 visits (in-person) for chemotherapy administration
Duration - Single infusion event
Participants receive an infusion of genetically engineered CARE T cells to target GPC3-positive solid tumors. The infusion occurs 48 to 96 hours after completing chemotherapy.
1 infusion visit (in-person)
Duration - Up to 8 weeks after infusion
Participants are monitored with physical exams, blood tests, scans, and optional tumor biopsies to assess treatment effects and tumor response.
Multiple visits including assessments at 1, 2, 4, and 6 weeks after infusion
Duration - Up to 15 years
Participants have blood drawn and health assessments to monitor the persistence of CAR T cells, long-term side effects, and overall health for up to 15 years.
Regular visits: weekly during first month, then every 3 months for 1 year, every 6 months for 4 years, then yearly visits
Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David Steffin
R
Ramy Sweidan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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