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

  • End date
    Feb 28, 2026
  • participants needed
  • sponsor
    St. Jude Children's Research Hospital
Updated on 8 April 2023
platelet count
renal function
metastatic disease
serum pregnancy test
measurable disease
gilbert's syndrome
shortening fraction
nucleic acid
kidney function tests
neutrophil count
chemotherapy regimen
pulse oximetry
cancer chemotherapy
solid tumor
cellular therapy
administration intravenous
left ventricular fractional shortening


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


Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-week evaluation period. The total study duration will be 1 year, at which point patients will enroll on our existing institutional long-term follow-up protocol.

Condition 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
Treatment cyclophosphamide, Fludarabine, MESNA, B7-H3 CAR T cells
Clinical Study IdentifierNCT04897321
SponsorSt. Jude Children's Research Hospital
Last Modified on8 April 2023


Yes No Not Sure

Inclusion Criteria

Treatment eligibility
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 Criteria

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note