Actively Recruiting
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
Led by Stanford University · Updated on 2026-05-07
41
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.
CONDITIONS
Official Title
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed malignant solid tumor with incurable disease and tumor recurrence or progression after standard therapies
- Neuroblastoma patients must have received or be intolerant to anti-GD2 antibody therapy
- Wilms tumor patients must have received or be intolerant to ifosfamide or cyclophosphamide plus etoposide or alternative salvage therapy
- Embryonal rhabdomyosarcoma patients must have received or be intolerant to Adriamycin-based therapy
- Surgically resected pulmonary osteosarcoma patients in first recurrence must have had surgical resection of metastatic nodules
- Evaluable or measurable disease during dose escalation; measurable disease in dose expansion except neuroblastoma which may have MIBG positive disease only
- Availability of archival tissue or willingness to undergo biopsy for B7-H3 expression analysis
- Age between 2 and 30 years; first three subjects must be between 12 and 30 years
- Karnofsky performance status 50% for patients over 16 years; Lansky scale 50% or ECOG = 2 for patients 16 years or younger
- No limit on prior therapies; washout periods required before leukapheresis
- Adequate organ and marrow function including ANC 750/uL, platelet count 75,000/uL, lymphocyte count 150/uL, and normal renal, hepatic, pulmonary, and cardiac function
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during and for four months after treatment
- Informed consent provided by participant or legal representative with assent as appropriate
You will not qualify if you...
- Current use of other investigational agents
- History of other malignancy except certain skin cancers or carcinoma in situ unless disease free for 3 years
- Untreated brain metastases; stable treated CNS tumor allowed
- Uncontrolled fungal, bacterial, viral or other infections
- Ongoing HIV or hepatitis B or C infection; history allowed if viral load undetectable
- Significant cardiac disease or events in past 12 months
- Medical conditions interfering with safety or efficacy assessment
- History of severe hypersensitivity to study agents
- Pregnancy or breastfeeding
- Primary immunodeficiency or autoimmune disease requiring systemic immunosuppression within 2 years
- Requirement for systemic corticosteroids or immunosuppressive therapy (with limited washout exceptions)
- Inability to complete protocol visits or comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
A
Amy Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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