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B7-H3 CAR T-cell Therapy for Relapsed/Refractory Solid Tumors

This study is testing a new cell therapy called B7-H3CART for children and young adults (ages 2 to 30) with solid tumors like neuroblastoma, sarcoma, and osteosarcoma that have come back or not responded to standard treatments. B7-H3CART uses your own immune cells, which are specially modified in a lab to find and fight cancer cells that have a specific marker called B7-H3. The main goals are to see if these cells can be successfully made and if the treatment is safe. We are also looking for the best dose to use in future studies. This study is currently unclear about its recruitment status and plans to enroll about 41 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 41 participants.
What's involved
Subjects who meet eligibility will receive B7-H3CART cells intravenously (into a vein) on Day 0.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and manufacturing feasibility for up to 2 years.

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NCT06500819

Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors

Recruiting
PHASE1Ages 2–30InterventionalTreatment
Stanford University
~41 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:B7-H3CART Dose (Intravenous)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of manufacturing autologous T cells
Measured over 2 years
+1 more outcome measured

Conditions

Neuroblastoma
Sarcoma
Osteosarcoma

Explore related trials

Embryonal RhabdomyosarcomaEwing SarcomaNeuroblastomaOsteosarcomaSoft Tissue SarcomaSolid NeoplasmWilms Tumor

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sneha Ramakrishna, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Amy Li
[email protected]
650-497-8953
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

ANC ≥ 750/uL\*
Platelet count ≥ 75,000/uL\*
Absolute lymphocyte count ≥ 150/uL\*
Adequate renal, hepatic, pulmonary and cardiac function defined as:
Creatinine within institutional norms for age(i.e. ≤ 2 mg/dL in adults or according to table below in children \<18 years) OR creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
Serum ALT/AST ≤ 2.5x ULN (unless elevated ALT/AST is associated with disease involvement of the liver, in which case this criterion will be waived and not disqualify a patient).
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO,
No clinically significant ECG findings
No clinically significant pleural effusion
Baseline oxygen saturation \> 92% on room air
if cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies. 8. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential). 9. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or for as long as CART cells are detectable in peripheral blood. 10. Must provide informed consent. For subjects \<18 years old, or adults with limited decision-making capacity, their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and assent will be obtained for those \> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he/she will be asked to reconsent as an adult.

What this trial measures

  • Feasibility of manufacturing autologous T cells2 years

    Feasibility of manufacturing autologous T cells transduced with Ef1a-CAR276 lentiviral vector expressing B7-H3 Chimeric Antigen Receptor (B7-H3-CART), using the Miltenyi CliniMACS Prodigy® system with dasatinib and protamine sulfate.

  • Safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of a single dose of intravenous B7-H3CART2 years

    Assess the safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of a single dose of intravenous B7-H3CART in children and young adults with relapsed and refractory solid tumors (i.e. soft tissue sarcoma, osteosarcoma, Ewing sarcoma, Wilms tumor, neuroblastoma) using the proposed dose escalation schedule.