Adoptive Therapy Using Antigen-Specific CD4 T-Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02210104|
Recruitment Status : Withdrawn (Issues with tetramer staining)
First Posted : August 6, 2014
Last Update Posted : July 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Sarcoma||Drug: Ipilimumab Drug: Cyclophosphamide Biological: CD4+ T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD4+ NY-ESO-1-Specific T Cells and Anti-CTLA4 For Patients With NY-ESO-1-Expressing Tumors|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
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.
Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.
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.
- Maximum Tolerated Dose (MTD) of Adoptively Transferred CD4 T Cells [ Time Frame: 12 weeks after T cell infusion ](MTD) defined as dose level below that at which excessive toxicity was observed. Dose limiting toxicity: Any ≥ Grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to ≤ Grade 1 severity within 2 weeks of starting therapy requires systemic treatment; Any ≥ Grade 3 bronchospasm or other hypersensitivity reaction; Any adverse event, laboratory abnormality or intercurrent illness which, in the judgment of the Investigator, presents a substantial clinical risk to the patient with continued dosing; Any other ≥ Grade 3 non-skin related adverse event.
- Clinical Response [ Time Frame: 6 weeks after T cell infusion ]Complete response (CR) defined as total regression of all tumors, a partial response (PR) as 30% or greater decrease in the sum of the longest diameter of target lesions and progressive disease (PD) as 20% increase in the sum of the longest diameter of target lesions (modified world health organization criteria or mWHO. Radiographic imaging (as clinically indicated) and clinical assessment of residual disease compared with pre-infusion assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210104
|Principal Investigator:||Cassian Yee, MD||M.D. Anderson Cancer Center|