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B7-H3.CD28Z.CART in CNS Neoplasms

NCT07390539 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-05

No results posted yet for this study

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)

Conditions

  • Central Nervous System Neoplasms
  • Brain Tumor
  • Brain Tumor, Recurrent
  • Brain Tumor, Pediatric
  • Brain Tumor Adult
  • Medulloblastoma
  • Medulloblastoma, Childhood
  • Medulloblastoma, Adult
  • Medulloblastoma Recurrent
  • Ependymoma
  • Atypical Teratoid/Rhabdoid Tumor
  • Embryonal Tumor With Multilayered Rosettes
  • Pineoblastoma
  • Leptomeningeal Disease

Interventions

BIOLOGICAL

B7-H3.CD28Z.CART

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

DRUG

Fludarabine

Lymphodepleting chemotherapy administered intravenously per institutional standards.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy administered intravenously per institutional standards.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Robbie Majzner

    lead OTHER

Principal Investigators

  • Susan Chi · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-08-31
Completion
2032-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07390539 on ClinicalTrials.gov