Programa de terapia de células T con receptores de antígeno quimérico

A continuación se enumeran ensayos clínicos actuales.

Filtrar esta lista de estudios según la ubicación, el estado del estudio y más.

1. 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.

    

2. Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

   Rochester, Minn., Jacksonville, Fla.

    

   The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.

3. A Study of JNJ‐68284528 Out‐of‐Specification (OOS) for Commercial Release in Patients with Multiple Myeloma

   Rochester, Minn.

   The purpose of this study is to evaluate the effectiveness of cilta-cel OOS based on overall response of partial response (PR) or better (overall response rate, ORR) to treat multiple myeloma.

4. MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

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

   Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.

5. Expanded Access Study For The Treatment Of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

   Rochester, Minn., Jacksonville, Fla.

   The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

6. A Study Evaluating The Safety And Effectiveness Of JCAR017 To Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Or Small Lymphocytic Lymphoma (SLL)

   Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to determine the effectiveness and safety of JCAR017 in adult subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the effectiveness and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

7. 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.

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

   Jacksonville, Fla., Rochester, Minn.

   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 Participants Treated With Gene-Modified T Cells

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

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

10. Axicabtagene Ciloleucel Versus Standard Of Care Therapy As First-Line Therapy In High-Risk Large B-Cell Lymphoma

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