Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4
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|ClinicalTrials.gov Identifier: NCT02027935|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2014
Last Update Posted : June 21, 2018
The goal of this clinical research study is to learn about the safety of giving CD8+T cells with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if this combination can help to control metastatic melanoma (melanoma that has spread).
This study is divided into 2 parts: leukapheresis and treatment. In the leukapheresis part, blood cells will be collected from you to be made into modified CD8+T cells and given back to you in the treatment part.
CD8+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory, and they are designed to find melanoma cancer cells and may kill them.
Ipilimumab and aldesleukin are designed to increase the immune system's ability to fight cancer.
Cyclophosphamide will be used at a very low dose to weaken the body's natural defense against the T-cell transplant, so that the transplanted T-cells have a chance to grow and multiply.
This is an investigational study. CD8+T cells are not FDA approved or commercially available. They are currently being used for research purposes only. Cyclophosphamide, ipilimumab, and aldesleukin are FDA approved and commercially available for the way they are being used in this study.
Up to 30 participants will be enrolled in this multicenter study. Up to 20 will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Cyclophosphamide Procedure: CD8+ T Cells Drug: Interleukin-2 Drug: Ipilimumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma|
|Actual Study Start Date :||January 22, 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: CD8+ T Cells + Cyclophosphamide + Interleukin-2 + Ipilimumab
Leukapheresis procedure performed to collect blood cells so they can be separated and grown as CD8+T cells. Cyclophosphamide administered at 300 mg/m2 by vein 2 days prior to T cell infusion. T cells administered at a dose of 10^10 cells/m2 by vein on Day 0. IL-2 250,000 U/m2 administered subcutaneously every 12 hours begins within 6 hours of T cell infusion and continues for a total of 14 days On Day 0 to Day +14. Ipilimumab administered 24 hours after T cell infusion at a dose of 3 mg/kg by vein. Subsequent infusions administered on Days +22, +43 and +64.
300 mg/m2 by vein 2 days prior to T cell infusion.
Procedure: CD8+ T Cells
T cells administered at a dose of 10^10 cells/m2 by vein on Day 0.
250,000 U/m2 administered subcutaneously every 12 hours begins within 6 hours of T cell infusion and continues for a total of 14 days On Day 0 to Day +14.
3 mg/kg by vein 24 hours after T cell infusion. Subsequent infusions administered on Days +22, +43 and +64.
- Overall Response [ Time Frame: 12 weeks ]Radiographic imaging and clinical assessment of residual disease compared with pre-infusion assessment. A complete response (CR) defined as total regression of all tumor, 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). Assessment performed 12 weeks following T cell infusion and then every 3 months until disease progression or intervening therapy, and the overall response rate (OR) after 1 cycle (12) weeks.
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): NCT02027935
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Adi Diab, MD||M.D. Anderson Cancer Center|