A Phase 1b Study of JNJ-90014496 in Adults with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

• Research type

  Research Study

• Full title

  A Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

• IRAS ID

  1008775

• Contact name

  David Wright

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2023-506267-33

• ISRCTN Number

  ISRCTN15038320

• Clinicaltrials.gov Identifier

  NCT05421663

• Research summary

  B-cell non-Hodgkin lymphoma (NHL) is a cancer that starts in specific type of white blood cells called B lymphocytes. The symptoms
  include lymph nodes (part of the body’s immune system) that are larger than normal, fever, and weight loss. Although treatments are
  available, it can come back after treatment (relapse) or can be resistant to standard treatment (refractory). There is a need for the
  continued development of safe and effective treatments. The study treatment, JNJ-90014496, is made by using a type of white blood cells (T-cells) from the participant. These cells are changed in the laboratory so that they attack cancer cells when they are put back into the participant’s blood. The purpose of this study is to see if JNJ-90014496 can be used in future studies for the treatment of B-cell Non-Hodgkin Lymphoma in adults. During the study, side effects caused by the study drug will be followed closely, as well as how long the study drug stays in the body and how the body responds to it. Men and women 18 years or older with B-cell NHL who have relapsed or refractory disease after 2 prior treatments will be enrolled.

  This study will be conducted in 2 parts which consists of run in and dose expansion.
  Run In: The participants will undergo lymphodepletion and then receive JNJ-90014496 through intravenous infusion on Day 1.
  Expansion: Participants will receive JNJ-90014496 infusion at the recommended phase 2 dose(s) confirmed after the Run In.
  Participants will be monitored for their long-term follow-up period after the post-treatment follow-up. Participants will undergo study
  assessments and tests, such as blood tests, and vital signs. Scans of the participants’ body will also be done to monitor disease
  status. The possible side effects of the study drug will be recorded during the study. Blood samples will be taken at multiple
  timepoints to understand how the body responds to study drug. The total duration of study is approximately 2 years and 7 months.

• REC name

  North East - York Research Ethics Committee

• REC reference

  24/NE/0006

• Date of REC Opinion

  1 Mar 2024

• REC opinion

  Further Information Favourable Opinion