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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06347068
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • iC9-CAR.B7-H3 T Cell Therapy — BIOLOGICAL
    iC9-CAR.B7-H3 T cells will then be administered intravenously
  • cyclophosphamide — DRUG
    cyclophosphamide 300 mg/m2 IV will be given.
  • fludarabine — DRUG
    fludarabine 30 mg/m2 IV will be given.

Study Details

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).

Key Dates

Start date
Jun 27, 2024
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iC9-CAR.B7-H3 T cells
    Specimen will be collected to prepare the iC9-CAR.B7-H3 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9-CAR.B7-H3 T cells. In part 2, the iC9-CAR.B7-H3 T cells are given by infusion after completion of lymphodepletion chemotherapy.

Primary Outcome Measure

Toxicity: NCI-CTCAE [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Catherine Cheng
[email protected]
919-445-4208
E. Claire Dees, MD, MSc (SUB_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina· Chapel Hill, NC

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