Clinical Trials Using Aldesleukin

Clinical trials are research studies that involve people. The clinical trials on this list are studying Aldesleukin. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 44
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  • A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

    This is a first in human, single arm, open label, Phase 1a / 1b study to determine the safety, feasibility, and efficacy of a single dose of NeoTCR-P1 T cells in participants with solid tumors.
    Location: 7 locations

  • FT516 in Subjects With Advanced Hematologic Malignancies

    This is a Phase 1 / 1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.
    Location: 4 locations

  • TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)

    The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 or 8 (MAGEA4 / 8.
    Location: 4 locations

  • OKT3 / Humanized 3F8 Bispecific Antibody-Activated T Lymphocytes, Aldesleukin, and Sargramostim in Treating Younger Patients with GD2-Positive Metastatic, Recurrent or Refractory Solid Tumors

    This phase I / II trial studies the side effects and best dose of OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes with given together with aldesleukin and sargramostim and to see how well they work in treating younger patients with disialoganglioside GD2 (GD2)-positive solid tumors that have spread to other parts of the body (metastatic), have come back (recurrent), or do not respond to treatment (refractory). Biological therapies, such as OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Aldesleukin and sargramostim may stimulate white blood cells to kill tumor cells. Giving white blood cells that have been activated by OKT3 / humanized 3F8 bispecific antibody-activated T lymphocytes with aldesleukin and sargramostim may kill more tumor cells.
    Location: 4 locations

  • FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

    This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
    Location: 3 locations

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.
    Location: 3 locations

  • TCR-engineered T Cells in Solid Tumors

    The study purpose is to establish the safety and tolerability of IMA203 product in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).
    Location: 3 locations

  • TCR-engineered T Cells in Solid Tumors: IMA202-101

    The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).
    Location: 3 locations

  • Cell Therapy (CIML NK Cells) for the Treatment of Recurrent Myeloid Disease after Donor Blood Stem Cell Transplant

    This phase I trial studies the side effects and best dose of cell therapy (CIML NK cells) in treating patients with myeloid disease that has come back (recurrent) after undergoing a donor blood stem cell transplant. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CIML NK cells may recognize and kill cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill myeloid cells. Giving CIML NK cells with aldesleukin may increase the levels of NK cells and kill more myeloid cells.
    Location: 2 locations

  • High-Dose Interleukin-2, Ipilimumab and Nivolumab for the Treatment of Patients with Stage III-IV Melanoma

    This phase II trial studies how well high dose interleukin-2 (IL-2) and ipilimumab followed by nivolumab works in treating patients with stage III-IV melanoma. IL-2 is an immunotherapy drug that increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving high-dose IL-2 together with ipilimumab and nivolumab may work better than nivolumab or pembrolizumab alone, and it may also improve anti-cancer activity in treating patients with melanoma.
    Location: Moffitt Cancer Center, Tampa, Florida

  • CISH Inactivated Tumor-Infiltrating Lymphocytes for the Treatment of Metastatic Gastrointestinal Epithelial Cancer

    This phase I / II trial evaluates the side effects and best dose of CISH inactivated tumor-infiltrating lymphocytes in patients with gastrointestinal epithelial cancer that has spread to other places in the body (metastatic). CISH inactivated tumor-infiltrating lymphocytes are created from immune cells extracted from a patient's own tumor cells. The immune cells are modified to make them more effective at finding and killing tumor cells. The purpose of this trial is to determine if CISH inactivated tumor-infiltrating lymphocytes are safe and effective as a treatment for gastrointestinal epithelial cancer.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Modified Immune Cells (LN-145) for the Treatment of Pretreated Metastatic Triple Negative Breast Cancer

    This phase II trial studies how well modified immune cells (LN-145) work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). LN-145 is made up of specialized white blood cells called lymphocytes or “T cells” that are derived from a patient's tumor after a small piece is obtained by surgical removal. This piece of the patient's tumor is sent to a centralized manufacturing facility where T cells that have infiltrated the tumor are isolated and grown to create LN-145, which is infused back into the body. Tumor infiltrating lymphocyte therapy with LN-145 involves expanding and activating tumor-derived T cells in vitro (in tissue culture) and then infusing the cells back into the patient where they may then attack the tumor.
    Location: Yale University, New Haven, Connecticut

  • Lymphodepletion with Adoptive Cell Therapy and High-Dose IL-2 for the Treatment of Metastatic Soft Tissue Sarcoma in Young Adult Patients

    This phase I trial studies the side effects of adoptively transferred tumor-specific T cells and high-dose aldesleukin (IL-2) and to see how well they work in treating patients with soft tissue sarcoma that has spread to other parts of the body (metastatic). Fludarabine and cyclophosphamide are two types of chemotherapy drugs used in lymphodepletion. The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the body before tumor infiltrating lymphocytes are infused. This is so that there will be more “space” for the lymphocytes that will be infused in the veins. Tumor-infiltrating lymphocytes involve the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system. These special immune T-cells are taken from a sample of tumor tissue that is surgically removed, then multiplied in a laboratory, and infused back into the patient. IL-2 may help the body's response to treatment on the immune system.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Cancer or Stage III-IV Cutaneous or Mucosal Melanoma

    This phase I trial studies the possible benefits and / or side effects of autologous tumor infiltrating lymphocytes and high-dose IL-2 in treating patients with head and neck squamous cell cancer that has come back (recurrent) or has spread to other places in the body (metastatic) or stage III-IV cutaneous or mucosal melanoma. Autologous tumor infiltrating lymphocytes are special tumor-fighting cells that are taken from patients’ tumors, grown in the laboratory, and then given back to the patient to fight their cancer. High-dose IL-2 increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving autologous tumor infiltrating lymphocytes and high-dose IL-2 may kill more cancer cells and help researchers learn more about the transfer of autologous tumor infiltrating lymphocytes to treat cancer.
    Location: University of California San Diego, San Diego, California

  • High Dose IL-2 and Nivolumab in Treating Patients with Stage III-IV Melanoma or Kidney Cancer

    This phase II trial studies how well high dose IL-2 and nivolumab work in treating patients with stage III-IV melanoma or kidney cancer. Immunotherapy with high dose IL-2 may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving high dose IL-2 and nivolumab may work better in treating patients with melanoma or kidney cancer compared to high dose IL-2 or nivolumab alone.
    Location: University of California San Diego, San Diego, California

  • Cell Therapy for the Treatment of Locally Advanced, Metastatic, or Recurrent Solid Cancers

    This phase II trial studies how well cell therapy (with tumor infiltrating lymphocytes) works for the treatment of solid cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other parts of the body (metastatic), or has come back (recurrent). This trial involves taking cells called lymphocytes (a type of white blood cell) from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called tumor infiltrating lymphocytes and the therapy is called cell therapy. Giving chemotherapy drugs, such as cyclophosphamide and fludarabine, before treating with these cells may temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. Giving aldesleukin after the cell administration may help the tumor fighting cells stay alive longer. Giving tumor fighting cells (tumor infiltrating lymphocytes) followed by aldesleukin may cause the cancer to shrink.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Palliative Radiation Therapy, Aldesleukin, and Nivolumab with or without Ipilimumab in Treating Patients with Refractory Metastatic Melanoma

    This phase II trial evaluates response rate and toxicity of standard palliative radiation therapy in combination with aldesleukin and nivolumab given with or without ipilimumab in treating patients with melanoma that has spread to places in the body (metastatic). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Aldesleukin stimulates white blood cells including T cells and natural killer cells to kill melanoma cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy may prime the immune system and make the cancer more susceptible to the immunotherapy drugs aldesleukin and nivolumab / ipilimumab given in sequential combination.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Cell Therapy (Tumor Infiltrating Lymphocytes) and Aldesleukin in Treating Patients with Locally Advanced, Recurrent, Refractory, or Metastatic Biliary Tract Cancers

    This phase II trial studies how well tumor infiltrating lymphocytes and aldesleukin work in treating patients with biliary tract cancers that has spread to other places in the body, has come back, or does not respond to treatment. Tumor infiltrating lymphocytes are a type of white blood cells which are taken from patients' tumors, grown in the laboratory in large numbers, and then given back to the patient to fight the tumor. Before receiving the cells, chemotherapy drugs called cyclophosphamide and fludarabine are given to temporarily suppress the immune system to improve the chances that the tumor fighting cells will be able to survive in the body. After the cells are given, aldesleukin may help the tumor fighting cells stay alive longer. This study is being done to see if giving tumor infiltrating lymphocytes and aldesleukin will cause biliary tract tumors to shrink.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Genetically engineered cells (NY-ESO-1 TCR engineered T cells and HSCs) after Melphalan Conditioning Regimen in Treating Patients with Recurrent or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    This phase I trial studies the best dose and side effects of NY-ESO-1 T cell receptor (TCR) engineered T cells and how well they work with NY-ESO-1 TCR engineered hematopoietic stem cells (HSCs) after melphalan conditioning regimen in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) or does not respond to treatment (refractory). The melphalan conditioning chemotherapy makes room in the patient’s bone marrow for new blood cells and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR T cells and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer. Giving NY-ESO-1 TCR engineered T cells and HSCs after melphalan may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • Tumor Infiltrating Lymphocytes and Chemotherapy with or without Immunotherapy in Treating Patients with Metastatic Melanoma

    This early phase I trial studies the side effects and how well tumor infiltrating lymphocytes and chemotherapy with or without immunotherapy work in treating patients with melanoma that has spread to other places in the body (metastatic). Specific cells, such as tumor infiltrating lymphocytes developed from the immune cells found within a patient's tumor masses may help to target tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving tumor infiltrating lymphocyte and chemotherapy with or without immunotherapy may work better in treating patients with melanoma.
    Location: Yale University, New Haven, Connecticut

  • Aldesleukin, Hypofractionated Radiation Therapy, and Pembrolizumab in Treating Patients with Advanced, Refractory Solid Tumors or Lymphoma

    This phase I / II trial studies how well aldesleukin, hypofractionated radiation therapy, and pembrolizumab work in treating patients with solid tumors or lymphoma that have spread to other places in the body (advanced) and or do not respond to treatment (refractory). Aldesleukin is an immunotherapy drug that increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin, hypofractionated radiation therapy, and pembrolizumab may offer significant clinical benefit to patients who fail to respond to pembrolizumab alone.
    Location: University of California Davis Comprehensive Cancer Center, Sacramento, California

  • Cyclophosphamide, Fludarabine, Tumor Infiltrating Lymphocytes, and Aldesleukin in Treating Patients with Metastatic Uveal Melanoma

    This phase II trial studies how well cyclophosphamide, fludarabine, tumor infiltrating lymphocytes, and aldesleukin work in treating patients with uveal melanoma that has spread to other places in the body. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Tumor infiltrating lymphocytes may be an effective treatment for uveal melanoma. Aldesleukin may stimulate white blood cells to kill uveal melanoma cells. Giving cyclophosphamide, fludarabine, tumor infiltrating lymphocytes, and aldesleukin may kill more tumor cells.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • LN-145 or LN-145-S1 in Treating Patients with Relapsed or Refractory Ovarian Cancer, Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas

    This phase II trial studies how well autologous tumor infiltrating lymphocytes LN-145 (LN-145) or LN-145-S1 works in treating patients with ovarian cancer, anaplastic thyroid cancer, osteosarcoma, or other bone and soft tissue sarcomas that do not respond to treatment (refractory) or that has come back (relapsed). LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the patient's tumor. LN-145-S1 is made using a modified process that chooses a specific portion of the T-cells. The T cells may specifically recognize, target, and kill the tumor cells.
    Location: M D Anderson Cancer Center, Houston, Texas

  • HERV-E TCR Transduced CD8+ / CD34+ T-cells in Treating Patients with Metastatic Clear Cell Renal Cell Cancer

    This phase I trial studies the side effects of HERV-E TCR transduced CD8+ / CD34+ T-cells in treating patients with clear cell renal cell cancer that has spread to other places in the body. HERV-E is a viral molecule of the HERVs family that becomes active in cancer cells and has been found in the surface of kidney tumor cells (not in healthy human normal cells). The incorporation of HERV-E into lymphocytes (T cells) may enable the immune system to recognize and fight kidney cancer cells.
    Location: National Heart Lung and Blood Institute, Bethesda, Maryland

  • T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients with Recurrent Ovarian Cancer

    This phase I / Ib trial studies the side effects and best dose of utomilumab and how well it works with CD8-positive T-lymphocyte (T-cell infusion) and aldesleukin in treating patients with ovarian cancer that has come back. Aldesleukin may stimulate white blood cells to kill ovarian cancer cells. Giving white blood cells (T-cells) that have been activated by a vaccine with aldesleukin may kill more tumor cells. Immunotherapy with utomilumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving T-cell infusion with aldesleukin and utomilumab may work better in treating patients with ovarian cancer.
    Location: M D Anderson Cancer Center, Houston, Texas


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