Clinical Trials Using Anti-CD19/CD28/CD3zeta CAR Gammaretroviral Vector-transduced Autologous T Lymphocytes KTE-C19

Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-CD19/CD28/CD3zeta CAR Gammaretroviral Vector-transduced Autologous T Lymphocytes KTE-C19. 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 1-12 of 12
  • A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed / Refractory Indolent Non-Hodgkin Lymphoma

    This study will enroll approximately 160 adult subjects who have relapsed or refractory (r / r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
    Location: 16 locations

  • Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed / Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed / Refractory B-Cell Non-Hodgkin Lymphoma

    The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed / refractory (r / r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r / r) B-cell non-Hodgkin lymphoma (NHL).
    Location: 14 locations

  • Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in Adults With Relapsed / Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

    The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed / refractory chronic lymphocytic leukemia (r / r CLL) and small lymphocytic lymphoma (r / r SLL).
    Location: 16 locations

  • Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma

    The primary objectives of this study are: Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab in participants with refractory large B-cell lymphoma
    Location: 8 locations

  • Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma

    The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2. Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.
    Location: 6 locations

  • Axicabtagene Ciloleucel and Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity in Recurrent or Refractory B Cell Lymphoma Patients

    This phase II trial studies how well axicabtagene ciloleucel in combination with anakinra works in preventing chimeric antigen receptor (CAR)-T cell mediated neurotoxicity in patients with B cell lymphoma that has come back (recurrent) or not responded to treatment (refractory). Axicabtagene ciloleucel is a drug that uses patient's own immune cells, called T cells, to try to kill cancerous cells. The primary risks observed in interventions like axicabtagene ciloleucel are cytokine release syndrome (CRS) and neurological toxicities. CRS is a group of symptoms caused by the release of chemicals from cells during the infusion. This can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash. It is thought that a protein called IL-1 may play a critical role in the formation of both CRS and neurological toxicities. Anakinra is a type of inhibitor that works by inhibiting (blocking) the protein IL-1. Giving axicabtagene ciloleucel in combination with anakinra may work to block this protein and decrease the risk of experiencing CRS and neurological toxicity.
    Location: 3 locations

  • Anakinra for the Reduction of CAR-T Toxicity in Patients with Relapsed or Refractory Large B-cell Lymphoma

    This phase II trial studies the side effects and best dose of anakinra and to see how well it works in reducing side effects (toxicity) associated with a CAR-T cell treatment called axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Anakinra is a drug typically used to treat rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory large B-cell lymphoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Acalabrutinib and Anti-CD19 CAR T-cell therapy for the Treatment of B-cell Lymphoma

    This phase I / II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

    The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.
    Location: 8 locations

  • Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients with Recurrent or Refractory Large B-cell Lymphoma

    This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body’s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients with B-Cell Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy

    This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy may be complicated by two potentially life-threatening side effects: CRS and neurotoxicity. Anakinra is a drug typically used to treat rheumatoid arthritis, but may also help in preventing CAR-T cell-related cytokine release syndrome and neurotoxicity.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients with Blood Cancer

    This phase II study investigates how well tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) work in treating patients with CD19 positive acute lymphoblastic leukemia, large B-cell lymphoma, or diffuse large B cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Tisagenlecleucel and axicabtagene ciloleucel are types of CAR-T therapy. Immunotherapy with tisagenlecleucel or axicabtagene ciloleucel, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to collect information on CAR-T product treatment and provide a structure to save and report data on treatment using these products.
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota