Adoptive Therapy Using Antigen-Specific CD4 T-Cells
NCT02210104 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2017-07-21
Summary
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.
Conditions
- Melanoma
- Sarcoma
Interventions
- DRUG
-
Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.
- DRUG
-
300 mg/m2 administered intravenously 2 days prior to T cell infusion.
- BIOLOGICAL
-
CD4+ T cells
Antigen-specific CD4+ T cells administered at a dose of 10\^10 cells/m\^2 on Day 0.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Cassian Yee, MD · M.D. Anderson 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
- 2016-12-31
- Primary Completion
- 2019-12-31
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