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 2026-04-15
48
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells
CONDITIONS
Official 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 old or younger
- Diagnosed with a B7-H3-positive solid tumor confirmed by immunohistochemistry with measurable disease
- Life expectancy greater than 12 weeks
- Karnofsky or Lansky performance score of 50 or higher
- For females of childbearing age: not pregnant with negative pregnancy test within 7 days before enrollment and not breastfeeding
- Eligible to undergo or previously undergone autologous apheresis for T-cell collection
- Evidence of relapsed or refractory disease after standard first-line therapy
- Life expectancy greater than 8 weeks
- Echocardiogram showing ventricular ejection fraction greater than 40% or shortening fraction 25% or higher
- Adequate kidney function defined by creatinine clearance or GFR thresholds
- Adequate lung function with pulse oximetry 92% or higher on room air or forced vital capacity 50% or higher of predicted
- Total bilirubin less than or equal to 3 times the upper limit of normal except for Gilbert's syndrome
- ALT or AST less than or equal to 5 times the upper limit of normal
- Hemoglobin 7 g/dL or higher (transfusions allowed)
- Platelet count above 50,000/uL (transfusions allowed)
- Absolute neutrophil count 1000/uL or higher
- Recovery from all severe non-hematologic toxicities from prior therapy
- If sexually active, agreement to use birth control until 3 months after T-cell infusion; male partners should use condoms
- Availability of autologous transduced T-cell product meeting manufacturing criteria
- Agreement to participate in long-term follow-up for genetically modified cell products
You will not qualify if you...
- Known primary immunodeficiency
- Known HIV infection
- Severe uncontrolled bacterial, viral, or fungal infection including active hepatitis B, hepatitis C, or adenovirus
- History of severe allergic reactions to murine protein-containing products
- Receiving systemic steroids over 0.5 mg/kg/day methylprednisolone equivalent within 7 days before CAR T-cell infusion
- Receiving systemic therapy within 14 days before CAR T-cell infusion that may interfere with B7-H3-CAR T-cell activity
- Rapidly progressing disease as judged by study investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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