Clinical Trials Using Therapeutic Allogeneic Lymphocytes

Clinical trials are research studies that involve people. The clinical trials on this list are studying Therapeutic Allogeneic Lymphocytes. 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 71
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  • QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

    This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1 / PD-L1 immune checkpoint inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1 / PD-L1 checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1 / PD-L1 checkpoint inhibitor, N-803, and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.
    Location: 11 locations

  • Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation

    The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.
    Location: 9 locations

  • Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

    The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and / or cyclophosphamide, or ALLO-647 alone.
    Location: 10 locations

  • Dose-escalation Study of Safety of PBCAR0191 in Patients With r / r NHL and r / r B-cell ALL

    This is a Phase 1 / 2a, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR0191 in adults with r / r B ALL (Cohort A) and in adults with r / r B-cell NHL (Cohort N).
    Location: 9 locations

  • Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed / Refractory Large B Cell or Follicular Lymphoma

    The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
    Location: 6 locations

  • A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

    This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
    Location: 8 locations

  • Dose-escalation Study of Safety of PBCAR20A in Subjects With r / r NHL or r / r CLL / SLL

    This is a Phase 1 / 2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult study participants with r / r B-cell NHL (Cohort A) or r / r CLL / SLL (Cohort B).
    Location: 5 locations

  • Study Evaluating Safety and Efficacy of UCART123 in Patients With Relapsed / Refractory Acute Myeloid Leukemia

    Phase I, first-in-human, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of UCART targeting CD123 in patients with relapsed / refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of one infusion of UCART123 and determine the Maximum Tolerated Dose (MTD).
    Location: 5 locations

  • Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed / Refractory Large B Cell Lymphoma (ALPHA-2)

    The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
    Location: 4 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

  • QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy

    Phase 2, single-arm study to evaluate combination therapy of avelumab, haNK and N-803 in patients with Merkel Cell Carcinoma who have progressed on or after checkpoint inhibitor therapy as assessed by ORR. Patients will receive treatment for a maximum of two years.
    Location: 5 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

  • Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT

    This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT). The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry. The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.
    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

  • Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

    Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
    Location: 3 locations

  • Donor-Derived Tumor-Associated Antigen-Specific T Cells in Treating Participants with Relapsed or Refractory acute myeloid leukemia or myelodysplastic syndrome

    This phase I trial studies the best dose and how well donor-derived multi-tumor-associated antigen specific T cells work in treating participants with acute myeloid leukemia or myelodysplastic syndrome that have come back or does not respond. Tumor associated antigen-specific T cells are immune system cells that may target cell proteins specific to tumor cells.
    Location: 3 locations

  • Donor-Derived Tumor Associated Antigen-Specific T Cells in Treating Participants with Recurrent or Refractory Acute Lymphoblastic Leukemia

    This phase I trial studies the side effects and best dose of donor-derived tumor associated antigen-specific T cells and how well they work in treating participants with acute lymphoblastic leukemia that has come back or does not respond to treatment. Tumor-associated antigen-specific T cells are immune system cells that may target cell proteins specific to tumor cells.
    Location: 3 locations

  • LMP1 / BARF1 / EBNA1-Specific Cytotoxic T-Lymphocytes with or without Cyclophosphamide and Fludarabine in Treating Participants with EBV-Positive Lymphoma

    This phase I trial studies the side effects and best dose of LMP1 / BARF1 / EBNA1-specific cytotoxic T-lymphocytes when given together with or without cyclophosphamide and fludarabine in treating participants with Epstein-Barr virus (EBV)-positive lymphoma. Immunotoxins, such as LMP1 / BARF1 / EBNA1-specific cytotoxic T-lymphocytes, are antibodies linked to a toxic substance and may help find certain cancer cells and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, 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. Giving LMP1 / BARF1 / EBNA1-specific cytotoxic T-lymphocytes, cyclophosphamide, and fludarabine together may work better in treating participants with EBV-positive lymphoma.
    Location: 3 locations

  • CD19.CAR T Cells in Treating Participants with CD19 Positive Malignancies after Stem Cell Transplant

    This phase I trial studies the side effects and best dose of CD19.CAR T cells in treating participants with CD19 positive malignancies after stem cell transplant. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T lymphocytes, such as CD19.CAR T cells, may kill tumor cells but there normally are not enough of them to kill all the tumor cells.
    Location: 3 locations

  • Genetically Modified T-Cells in Treating Patients With Advanced Non-Hodgkin's Lymphoma

    This phase I trial studies the side effects and the best dose of genetically modified T-cells in treating patients with advanced non-Hodgkin's lymphoma. Biological therapies, such as genetically modified T-cells may stimulate or suppress the immune system in different ways and stop cancer cells from growing.
    Location: 3 locations

  • Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

    This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).
    Location: 5 locations

  • CIML NK Cells and Nogapendekin Alfa Alone or in Combination with Ipilimumab for the Treatment of Recurrent or Metastatic Head and Neck Cancer

    This phase I trial investigates the side effects and best dose of CIML-NK cells when given together with nogapendekin alfa alone or in combination with ipilimumab, in treating patients with head and neck squamous cell cancer that has come back (recurrent) or spread to other places in the body (metastatic). CIML NK cells come from a haploidentical donor (cells from another person with similar immune proteins). They have been bathed in special proteins to help identify and treat certain cancers. Nogapendekin alfa works by using the body’s immune system and stimulating it to increase the number of immune cells that kill tumor cells. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this trial is to obtain information on the safety and effectiveness of this combination of study drugs to treat head and neck cancer.
    Location: 2 locations

  • A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A in Study Participants With Relapsed / Refractory Multiple Myeloma

    This is a Phase 1 / 2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with r / r MM.
    Location: 4 locations

  • Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

    This is a Phase I, first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety, tolerance, clinical activity of UCART22 and to determine the Maximum Tolerated Dose (MTD).
    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


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