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Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

NCT06347068 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-22

No results posted yet for this study

Summary

This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).

Conditions

Interventions

BIOLOGICAL

iC9-CAR.B7-H3 T Cell Therapy

iC9-CAR.B7-H3 T cells will then be administered intravenously

DRUG

cyclophosphamide

cyclophosphamide 300 mg/m2 IV will be given.

DRUG

fludarabine

fludarabine 30 mg/m2 IV will be given.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Yara E Abdou, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-27
Primary Completion
2026-05-31
Completion
2028-05-31
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 NCT06347068 on ClinicalTrials.gov