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

NCT06500819 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-05-07

No results posted yet for this study

Summary

The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.

Conditions

Interventions

DRUG

B7-H3CART Dose (Intravenous)

Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level -1 (DL-1) 0.3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 1 (DL1) 1 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 2 (DL2) 3 x 106 transduced T cells/kg Subjects who meet cell infusion eligibility will receive IV B7-H3CART cells on Day 0. Dose level 3 (DL3) 9 x 106 transduced T cells/kg

Sponsors & Collaborators

Principal Investigators

  • Sneha Ramakrishna, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT06500819 on ClinicalTrials.gov