Autologous CAR-T Cells Targeting B7-H3 in PDAC

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

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06158139
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pancreas Cancer
  • Relapse
  • Resistant Cancer

Eligibility Criteria

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

Interventions

  • iC9-CAR.B7-H3 T cell infusion — BIOLOGICAL
    iC9-CAR.B7-H3 T cell product will be administered via intravenous injection over 5 - 10 minutes.

Study Details

The purpose of this gene therapy research study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in patients with pancreatic ductal adenocarcinoma that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration.

Key Dates

Start date
Jul 18, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

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

Arms

  • Experimental: CAR-T Cell Therapy
    Single Arm Subjects with Refractory Pancreatic Ductal Adenocarcinoma (PDAC) cancer will receive iC9.CAR.B7-H3 T cells manufactured from their collected blood sample.

Primary Outcome Measure

Number of participants with adverse event [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Caroline Babinec
[email protected]
919-966-5902
Ashwin Somasundaram, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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