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Cyclophosphamide

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Ipilimumab

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Immune Checkpoint Inhibitors

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.

Antigen-specific CD4+ T cells administered at a dose of 10\^10 cells/m\^2 on Day 0.

CD4+ T cells

Cassian Yee, MD

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.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. The first 3 or 6 participants will receive a lower dose of ipilimumab. If there are no intolerable side effects, then the second group of 6 participants will receive a higher dose of ipilimumab.

All study participants will receive the same dose level of cyclophosphamide and the CD4+T cells.

Study Drug Administration:

You will receive cyclophosphamide by vein over about 30-60 minutes on Day -2 (2 days before you receive the CD4+T cells). If the doctor thinks it is needed, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

On Day 0, you will receive the CD4+T cells by vein over about 30-60 minutes. You will stay in the hospital overnight after the dose.

On Days 1, 22, 43, and 64, you will receive ipilimumab by vein over about 90 minutes.

Study Visits:

Within 2-4 weeks before you receive the CD4+T cells:

* You will have a physical exam.
* Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.
* You will have a computed tomography (CT) scan or x-rays to check the status of the disease.

On Day -2:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests. This routine blood draw will include a pregnancy test if you can become pregnant.

On Day 1:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.

On Days 0, 7, 14, 22, 28, 35, 43, 49, and 56:

* You will have a physical exam.
* Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.

On Day 3, blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.

Between Day 35 and 42 and again between Day 77 and 84, you will have a CT scan or x-rays to check the status of the disease.

The study tests may be repeated or you may have additional tests performed anytime the doctor thinks it is needed.

Some of the study tests may be done at your local clinic if you cannot return to MD Anderson. The study staff will discuss this with you.

Length of Study Drug Dosing:

Your last study drug dose will be on Day 64. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up.

End-of-Study-Drug-Dosing Visit:

On Day 64:

* You will have a physical exam.
* Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.

Follow-Up:

On Days 70, 77, 84, 105, 126, 147, and 168:

* You will have a physical exam.
* Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.

Every 3 months after Day 84, unless the disease gets worse or you start another cancer therapy, you will have a CT scan or x-rays to check the status of the disease. Every 3 months for up to 5 years, the study staff will call you or ask your doctor how you are doing. If you are called, the calls should last about 10-15 minutes.

If the doctor thinks it is needed to confirm the status of the disease, blood (about 1½ tablespoons) will be drawn every 3 months for up to 1 year.

If the doctor thinks it is needed, you will return to the clinic every 4-6 weeks starting after Day 168 or as often as the doctor thinks is needed. These visits will stop if the T-cells disappear or if the disease gets worse. Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and tests on how long the T-cells survive in your body.

This is an investigational study. CD4+T cells are not FDA approved or commercially available. They are currently being used for research purposes only. Cyclophosphamide is FDA approved and commercially available for the way it is being used in this study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma, but not for sarcoma. The study doctor can explain how the study drugs are designed to work.

Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.

Adoptive Therapy Using Antigen-Specific CD4 T-Cells

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

(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.

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.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adoptive Therapy Using Antigen-Specific CD4 T-Cells	NCT02210104	Melanoma Sarcoma	Ipilimumab Cyclophosphamid... CD4+ T cells	18 Years -	M.D. Anderson Cancer Center
Adoptive Therapy Using Antigen-Specific CD4 T-Cells	NCT02210104	Melanoma Sarcoma	Ipilimumab Cyclophosphamid... CD4+ T cells	18 Years -	M.D. Anderson Cancer Center
Adoptive Therapy Using Antigen-Specific CD4 T-Cells	NCT02210104	Melanoma Sarcoma	Ipilimumab Cyclophosphamid... CD4+ T cells	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for mixed round cell liposarcoma