Adoptive Therapy Using Antigen-Specific CD4 T-Cells

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02210104
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.
  • Cyclophosphamide — DRUG
    300 mg/m2 administered intravenously 2 days prior to T cell infusion.
  • CD4+ T cells — BIOLOGICAL
    Antigen-specific CD4+ T cells administered at a dose of 10\^10 cells/m\^2 on Day 0.

Study Details

The goal of this clinical research study is to learn about the safety of giving CD4+T cells with ipilimumab and cyclophosphamide. CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory, and they are designed to find cancer cells and may kill them.

Key Dates

Start date
Dec 31, 2016
Status verified
Jul 2017
Primary completion
Dec 31, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Cyclophosphamide + CD4+T Cells
    Starting Dose of Ipilimumab 1.0 mg /kg by vein on Days 1, 22, 43, and 64. Cyclophosphamide 300 mg/m2 administered intravenously 2 days prior to T cell infusion as an outpatient procedure. Antigen-specific CD4+ T cells administered at a dose 10\^10 cells/m\^2.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Adoptively Transferred CD4 T Cells [ Time Frame: 12 weeks after T cell infusion ]

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