JCAR017 In Adults With Aggressive B-Cell Non-Hodgkin Lymphoma (PH 2)

• Research type

  Research Study

• Full title

  A Phase 2, Single-Arm, Multi-Cohort, Multicenter Trial To Determine The Efficacy And Safety Of JCAR017 In Adult Subjects With Aggressive B-Cell Non-Hodgkin Lymphoma

• IRAS ID

  228293

• Contact name

  Kirit Ardeshna

• Contact email

  kirit.ardeshna@uclh.nhs.uk

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2017-000106-38

• Duration of Study in the UK

  4 years, 2 months, 0 days

• Research summary

  Research Summary:
  This is a phase 2 study for patients with aggressive B-cell Non-Hodgkin Lymphoma (NHL). JCAR017 is an experimental therapy being developed for the treatment of B-cell NHL. The purpose of this study is to determine if JCAR017 is safe and effective in treating B-cell NHL. The study is single arm (all patients will receive the experimental treatment) and will be open in multiple centres.

  JCAR017 is a type of therapy known as chimeric antigen receptor (CAR) T cell therapy. T cells are cells of the immune system which help to kill diseased cells in the body. Patients with lymphoma are believed to have defective T cells which do not recognize the lymphoma cells.

  JCAR017 T cell therapy involves modifying the patient’s own T cells so that they can recognise and destroy their lymphoma cells.

  The study is split into three sections, Pretreatment: which includes screening to check eligibility, Treatment and Follow Up.

  Pretreatment: If a patient is eligible according to the screening criteria, immune cells will be collected from the patient. These cells will be sent to a laboratory and JCAR017 cells will be manufactured. If required, patients will receive standard chemotherapy during the time it takes to manufacture the JCAR017 cells.
  
  Treatment: Patients will receive chemotherapy prior to the infusion of JCAR017 cells.

  Follow Up: patients will have follow up visits at months 2, 3, 6, 9, 12, 18 and 24 after the JCAR017 T cell infusion. The maximum time in this study is approximately 2.5 years.

  The study will take place at 2 NHS hospital sites in the UK and 12 patients are expected to be recruited. A total of 124 patients will take part worldwide.
  Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, MRI, PET, electrocardiogram, blood tests, questionnaires.

  Lay summary of study results:
  A lay summary is under preparation and will become available within the next months. The lay summary will be published on BMS.com and a PDF copy will be distributed to investigator sites to share with their patients as applicable.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  18/LO/0687

• Date of REC Opinion

  16 Jul 2018

• REC opinion

  Further Information Favourable Opinion