Actively Recruiting
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating an immunotherapy called B7-H3-CAR T cells for patients 21 years old or younger with relapsed or refractory B7-H3-positive solid tumors. This Phase I clinical trial aims to find the highest safe dose of these genetically modified T cells and assess their safety and anti-tumor effects. The study also explores changes in the tumor environment and immune system after treatment. Participants receive a single infusion of B7-H3-CAR T cells following a short course of chemotherapy to reduce immune cells, with dosing based on the number of CAR-positive T cells and patient weight. The study uses a standard 3+3 dose escalation design and monitors patients over a 6-week evaluation period. After one year in the study, patients can join a long-term follow-up program to monitor safety. During the study, patients will be closely observed for side effects and treatment impact on their cancer. Researchers will assess safety six weeks after the infusion and evaluate clinical response. The study includes regular monitoring of heart, kidney, and lung function, blood tests, and performance status assessments. Participants may also provide biological samples to study immune changes. The total participation time is one year, followed by long-term safety monitoring.
CONDITIONS
Brief Title
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosis of a B7-H3-positive solid tumor with measurable disease
- Relapsed or refractory disease after standard first-line therapy
- Estimated life expectancy greater than 8 weeks
- Karnofsky or Lansky performance score of 50 or higher
- Adequate heart function with ejection fraction over 40% or shortening fraction 25% or higher
- Adequate kidney function with creatinine clearance or GFR of at least 50 ml/min/1.73m2 (40 ml/min/1.73m2 if under 2 years old)
- Adequate lung function with pulse oximetry 92% or higher on room air or forced vital capacity 50% or higher
- Total bilirubin no more than 3 times upper limit normal (except Gilbert's syndrome)
- ALT or AST no more than 5 times upper limit normal
- Hemoglobin 7 g/dL or higher (transfusions allowed)
- Platelet count over 50,000/uL (transfusions allowed)
- Absolute neutrophil count 1000/uL or higher
- Recovery from prior severe non-blood toxicities
- For females of childbearing age: not pregnant with negative pregnancy test within 7 days prior, not breastfeeding, and agreement to use birth control until 3 months after infusion
- Availability of autologous transduced T-cell product meeting release criteria
- Agreement to participate in long-term follow-up for genetically modified cell therapy
You will not qualify if you...
- Known primary immunodeficiency
- Known HIV infection
- Severe, uncontrolled bacterial, viral, or fungal infections including active hepatitis B or C
- History of allergic reactions to murine protein-containing products
- Rapidly progressive disease as judged by study investigators
- Receiving systemic steroids exceeding 0.5 mg/kg/day methylprednisolone equivalent within 7 days before infusion
- Receiving systemic therapy within 14 days before CAR T-cell infusion that may interfere with CAR T-cell activity
- Pregnant or breastfeeding females
- Inability to undergo or prior failure of autologous apheresis for T-cell collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive lymphodepleting chemotherapy followed by a single infusion of B7-H3-CAR T cells. They are monitored for safety and effects of the treatment on their cancer.
Multiple visits during chemotherapy and infusion, with frequent monitoring visits for 6 weeks after infusion
Duration - Up to 1 year
Participants are monitored for long-term safety and treatment outcomes after the initial 6-week evaluation period.
Regular follow-up visits during the 1-year study period
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
C
Chris DeRenzo, MD
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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