A phase 2 study with JCAR017 in adults with B-cell NHL
Research type
Research Study
Full title
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)
IRAS ID
276831
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2019-004081-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
This is a phase 2 study for patients with a type of cancer called Follicular Lymphoma or Marginal Zone Lymphoma, which has either returned or is not responding to the current treatment. These are 2 cancer types of non-Hodgkin lymphoma (NHL).
JCAR017 is an experimental therapy being developed for the treatment of NHL. The purpose of this study is to determine if the experimental therapy called JCAR017 is effective and safe to treat NHL.
The study is single arm (all patients will receive the experimental treatment JCAR017) 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 white blood cells of the immune system which help to kill diseased cells in the body. Patients with NHL are believed to have defective T cells which do not recognise and kill the lymphoma cells.
To create the JCAR017 T cell experimental therapy, some T-cells will be collected from the patient's blood in a procedure called leukapheresis. A new gene will be inserted into the patient's T cells using a genetically modified virus. JCAR017 will then be given back to patients intravenously.
The study has 3 parts: Pre-treatment, Treatment and Follow-Up.
Pre-treatment: If a patient is eligible according to the screening criteria, T-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 approximately 2, 3, 6, 9, 12, 18, and 24 months after the JCAR017 T cell infusion.
A total of 188 patients worldwide will take part in this study across 4 patients groups.REC name
Scotland B REC
REC reference
20/SS/0036
Date of REC Opinion
4 Aug 2020
REC opinion
Further Information Favourable Opinion