Back to search results

B7-H3-Specific CAR T-Cell Therapy for Pediatric Solid Tumors

This study is testing a new type of immunotherapy called B7-H3 CAR T cells for children and young adults (up to 21 years old) with certain solid tumors that have returned or are not responding to other treatments. The CAR T cells are made from your own immune cells, which are specially trained to find and fight cancer cells that have a specific marker called B7-H3. Before receiving the B7-H3 CAR T cells, you will get chemotherapy (Fludarabine and Cyclophosphamide, with MESNA to protect your bladder). The main goal of this study is to see how safe the B7-H3 CAR T cells are and to find the highest dose that can be given safely. We are also looking to see if this treatment can shrink tumors. To join, your tumor must show the B7-H3 marker.

Study design
This is an interventional study with a planned enrollment of 48 participants. It is a Phase I study, meaning it focuses on safety and finding the right dose.
What's involved
Treatment involves a single infusion of B7-H3-CAR T cells after receiving chemotherapy. Safety will be evaluated for 6 weeks after the CAR T cell infusion.
Compensation
Not stated in the trial record.
Follow-up
The total study duration will be 1 year, after which patients will enroll in an existing long-term follow-up program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04897321

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Recruiting
PHASE1Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~48 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideMESNAB7-H3 CAR 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
Safety of B7-H3-CAR T cells
Measured over 6 weeks after B7-H3-CAR T cell infusion

Conditions

Pediatric Solid Tumor
Osteosarcoma
Rhabdomyosarcoma
Neuroblastoma
Ewing Sarcoma
Wilms Tumor
Adrenocortical Cancer
Desmoplastic Small Round Cell Tumor
Germ Cell Cancer
Rhabdoid Tumor
Clear Cell Sarcoma
Hepatoblastoma
Melanoma
Carcinoma
Malignant Peripheral Nerve Sheath Tumors
Soft Tissue Sarcoma

Explore related trials

CarcinomaClear Cell Sarcoma of Soft TissueDesmoplastic Small Round Cell TumorEwing SarcomaGerm Cell CancerHepatoblastomaMalignant Adrenal Cortical NeoplasmMalignant Peripheral Nerve Sheath TumorMelanomaNeuroblastomaOsteosarcomaRhabdoid TumorRhabdomyosarcomaSoft Tissue SarcomaSolid NeoplasmWilms TumorCD276 wt Allele

NCT04897321

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • St. Jude Children's Research Hospital

    Memphis, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Chris DeRenzo, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Chris DeRenzo, MD
[email protected]
888-226-4343
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≤21 years old
B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100
Estimated life expectancy of \>12 weeks
Karnofsky or Lansky (age-dependent) performance score ≥50
For females of child bearing age:
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Not lactating with intent to breastfeed
Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
Age ≤21 years old
B7-H3+ solid tumor with measurable disease
Evidence of relapsed or refractory disease after standard first-line therapy
Estimated life expectancy of \>8 weeks
Karnofsky or Lansky (age-dependent) performance score≥50
Echocardiogram with a ventricular ejection fraction
\>40%; or shortening fraction ≥25%
Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if \< 2 years of age)
Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value
Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age
Hemoglobin≥ 7g/dL (can be transfused)
Platelet count \>50,000/uL (can be transfused)
Absolute neutrophil count (ANC) ≥ 1000/uL
Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
For females of child bearing age:
Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
Not lactating with intent to breastfeed
If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.
Available autologous transduced T-cell product that has met GMP release criteria
Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products

Exclusion

Known primary immunodeficiency
Known HIV positivity
Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)
History of hypersensitivity reactions to murine protein-containing products
Rapidly progressive disease (in the opinion of the study PIs)
Known primary immunodeficiency
History of HIV infection
Severe, uncontrolled intercurrent bacterial, viral or fungal infection
History of hypersensitivity reactions to murine protein-containing products
Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion
Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).
Rapidly progressing disease (in the opinion of the study PIs)

What this trial measures

  • Safety of B7-H3-CAR T cells6 weeks after B7-H3-CAR T cell infusion

    A phase I design to determine the maximum tolerated dose (MTD) of autologous, B7-H3-CAR T cells. Four dose levels (3x10\^5/kg, 1x10\^6/kg, 3x10\^6/kg, and 1x10\^7/kg) will be evaluated.