RecruitingPhase 1NCT07390539

B7-H3.CD28Z.CART in CNS Neoplasms

A Phase 1/1b Study of Autologous b7-h3 Chimeric Antigen Receptor t Cells (b7-h3.cd28z.Cart) in Children and Young Adults With Recurrent or Progressive Cns Neoplasms Expressing b7-h3 Target


Sponsor

Robbie Majzner

Enrollment

70 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The names of the study investigational therapies involved in this study are: * Fludarabine (a type of chemotherapy) * Cyclophosphamide (a type of chemotherapy) * B7-H3 CAR T cells (a type of cellular therapy)


Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called B7-H3.CD28Z.CART, a drug called Cyclophosphamide, and others for people with atypical teratoid/rhabdoid tumor, brain tumor, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALB7-H3.CD28Z.CART

Autologous CAR T cells targeting B7-H3 (CD276), administered intravenously (into the vein) per protocol.

DRUGFludarabine

Lymphodepleting chemotherapy administered intravenously per institutional standards.

DRUGCyclophosphamide

Lymphodepleting chemotherapy administered intravenously per institutional standards.


Locations(2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07390539


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