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: 6 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

  • 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

  • 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: 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

  • Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

    Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells 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, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian / endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian / endometrial tumors to shrink and to see if this treatment is safe. Eligibility: - Adults age 18-70 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian / endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
    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

  • Non-Viral TCR Gene Therapy

    Background: A person s white blood cells can be modified in a lab to recognize certain changes in their tumor. Many of these cells are collected from the person, modified, then given back to the person. This may help treat some cancers. Objective: To learn if a person s white blood cells modified with T-cell receptors can cause solid tumors to shrink. Eligibility: People ages 18-70 who have cancer of the gastrointestinal tract, genitourinary tract, ovary, breast, or lung that has spread, or who have glioblastoma. Design: Participants will be screened and have their cells prepared for treatment in another protocol. Participants will be hospitalized one week before treatment. They will stay approximately 3 - 4 weeks after treatment. Participants will get the modified white blood cells and chemotherapy through an IV catheter, which is a small plastic tube inserted in a vein. Participants will take drugs by mouth to prevent infection. They will receive filgrastim as a shot or injection under the skin. Participants will have tests before, during, and after treatment: Heart, blood, and urine tests Chest X-ray Physical exam Scans: They will lie in a machine that takes pictures of the body. Possible apheresis: The participant s blood is removed through a needle in an arm. The blood goes through a machine that removes the white blood cells. The rest of the blood is returned through a needle in the other arm. Participants will have visits about 6 and 12 weeks after treatment. If they are responding to treatment, they will then have visits every 3-6 months for 3 years. Then they will join another study and be followed about 12 more years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • 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

  • 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

  • Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

    Background: A new cancer therapy takes white blood cells from a person, grows them in a lab, genetically changes them, then gives them back to the person. Researchers think this may help attack tumors in people with certain cancers. It is called gene transfer using anti-KRAS G12D mTCR cells. Objective: To see if anti-KRAS G12D mTCR cells are safe and cause tumors to shrink. Eligibility: Adults ages 18-70 who have cancer with a molecule on the tumors that can be recognized by the study cells Design: Participants will be screened with medical history, physical exam, scans, photography, and heart, lung, and lab tests. An intravenous (IV) catheter will be placed in a large vein in the chest. Participants will have leukapheresis. Blood will be removed through a needle in an arm. A machine will divide the blood and collect white blood cells. The rest of the blood will be returned to the participant through a needle in the other arm. A few weeks later, participants will have a hospital stay. They will: - Get 2 chemotherapy medicines by IV over 5 days. - Get the changed cells through the catheter. Get up to 9 doses of a medicine to help the cells. They may get a shot to stimulate blood cells. - Recover in the hospital for up to 3 weeks. They will provide blood samples. Participants will take an antibiotic for at least 6 months. Participants will have several follow-up visits over 2 years. They will repeat most of the screening tests and may have leukapheresis. Participants blood will be collected for several years.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • 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 Participants with Metastatic Uveal Melanoma

    This phase II trial studies how well cyclophosphamide, fludarabine, tumor infiltrating lymphocytes, and aldesleukin work in treating participants 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


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