برنامج علاج المستقبلات الخيمرية للخلايا التائية

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. 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.

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

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

   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.

3. Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in High-Risk Large B-Cell Lymphoma

   Rochester, Minn., Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).

4. PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

   Rochester, Minn.

   The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.

5. A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. Innovative CAR-TIL immunotherapy against melanoma

   Jacksonville, Fla.

   The chimeric antigen receptor (CAR) T-cell therapy is a revolutionary cellular immunotherapy strategy that has transformed the treatment of B cell malignancies by engineering T cells to recognize B cell specific tumor markers; however, attempts to treat solid tumors with CAR T-cells have identified unique challenges that have rendered CAR T cells less effective against these tumors. Conventional CARs are designed to target tumor-associated antigens, but antigenic heterogeneity and the variable nature of surface antigen expression provide escape mechanisms for solid tumors from CAR T-cell attack. [1, 2] The solid tumor stroma acts as an immunosuppressive cloud that impedes the homing of peripheral CAR T-cells into the tumor microenvironment (TME). The hostile TME can also drive CAR T-cells to functional exhaustion and metabolic dysfunction, thus blunting the therapeutic efficacy of CAR T-cells.[3] Oncolytic viruses or radiation that generate local inflammation in the TME have been shown to promote T cell homing and infiltration [4] but do not address the exhaustion of tumor infiltrating lymphocytes (TILs). The PD-1/PD-L1 cascade allows tumors to evade the immune system by suppressing T cell function within the TME. [5, 6] An ideal adoptive cellular therapy must possess the ability to not only return to the site of the tumor but must also retain cytotoxic potential after a recognition event. We present here a CAR design that allows PD-1 to recognize PD-L1 on the tumor; however, the intracellular CAR design is one that results in T cell activation as opposed to inhibition. We hypothesize that targeting melanoma with a PD-1 (MC9324) CAR TIL therapy would capitalize on the tumor homing machinery of the TIL to drive the CAR TIL to the tumor where engagement of the PD-1 domain of the CAR with PD-L1 on the tumor cell would result in T cell cytotoxic killing.

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

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

   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.

3. Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in High-Risk Large B-Cell Lymphoma

   Rochester, Minn., Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).

4. PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

   Rochester, Minn.

   The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.

5. A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.