Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

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

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06305299
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this 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 ovarian cancer 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. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.

Key Dates

Start date
Jul 29, 2024
Status verified
May 2026
Primary completion
Apr 30, 2036
Completion
Apr 30, 2036

Study Design

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

Arms

  • Experimental: Chimeric Antigen Receptors
    blood 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
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Caroline Babinec
[email protected]
Linda Van Le (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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