برنامج علاج المستقبلات الخيمرية للخلايا التائية

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders

   Jacksonville, Fla.

   The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including  systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.

    

2. A Study to Evaluate Remote Monitoring in Cancer Care

   Rochester, Minn.

   The objectives of this study are to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, and to develop patient-specific algorithms to predict the trajectory of CRS and or neurotoxicity and time to escalation of medical intervention is needed.

3. CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/​Refractory B Cell Malignancies

   Rochester, Minn.

   The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.

   The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified T cells are called the IC19/1563 treatment. The dose of IC19/1563 will depend on when the patient is enrolled on to the study.

    

4. Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.

5. A Study to Evaluate the Safety and Effectiveness of ALLO-501A CAR T Cell Therapy in Adults with Relapsed/ Refractory Large B Cell Lymphoma

   Scottsdale/Phoenix, Ariz.

   The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).

6. A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

7. Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/​Round Cell Liposarcoma

   Jacksonville, Fla.

   The purpose of this study is to evaluate genetically-engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.

8. A Study to Evaluate the Safety and Effectiveness of Idecabtagene Vicleucel to Treat Multiple Myeloma

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information. 

9. Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

10. Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

    Rochester, Minn.

    A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders

   Jacksonville, Fla.

   The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including  systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.

    

2. A Study to Evaluate Remote Monitoring in Cancer Care

   Rochester, Minn.

   The objectives of this study are to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, to establish the validity for the use of wearable device for continuous, remote monitoring of physiologic parameters, and to develop patient-specific algorithms to predict the trajectory of CRS and or neurotoxicity and time to escalation of medical intervention is needed.

3. CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/​Refractory B Cell Malignancies

   Rochester, Minn.

   The purpose of this study is to find out more about the side effects of the CAR-T therapy called IC19/1563 and what dose of IC19/1563 is safe for patients.

   The therapy, IC19/1563, uses some of the patients own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. In this study, some of the patient's T cells will be removed from their blood. In the laboratory, we will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat the cancer. The new modified T cells are called the IC19/1563 treatment. The dose of IC19/1563 will depend on when the patient is enrolled on to the study.

    

4. Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.

5. A Study to Evaluate the Safety and Effectiveness of ALLO-501A CAR T Cell Therapy in Adults with Relapsed/ Refractory Large B Cell Lymphoma

   Scottsdale/Phoenix, Ariz.

   The primary purpose of this study is to assess the safety and effectiveness of ALLO-501A to treat patients with relapsed/refractory large B cell lymphoma (LBCL) to determine the maximum tolerated dose (MTD).

6. A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

7. Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/​Round Cell Liposarcoma

   Jacksonville, Fla.

   The purpose of this study is to evaluate genetically-engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.

8. A Study to Evaluate the Safety and Effectiveness of Idecabtagene Vicleucel to Treat Multiple Myeloma

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information. 

9. Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

10. Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

    Rochester, Minn.

    A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.