75348780LYM1001

  • Research type

    Research Study

  • Full title

    A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL

  • IRAS ID

    290913

  • Contact name

    David Wright

  • Contact email

    dwrigh48@ITS.JNJ.com

  • Sponsor organisation

    Janssen-Cilag International NV

  • Eudract number

    2020-001183-29

  • Clinicaltrials.gov Identifier

    NCT04540796

  • Duration of Study in the UK

    2 years, 4 months, 3 days

  • Research summary

    B cell Non-Hodgkin lymphoma (NHL) is an uncommon cancer that develops in the lymphatic system, which is a network of vessels and glands spread throughout the body. Chronic lymphocytic leukaemia (CLL), a type of cancer affecting the white blood cells that develops slowly over time. The drug being studied is called JNJ-75348780, which is an investigational (or experimental) drug that has not been used in humans before but has only been studied in test tubes and animals. JNJ-75348780 is a liquid study drug given by injection into the body. The purpose of this research study is to find a safe dose of JNJ-75348780 that can be used for treating patients with NHL and CLL. Another purpose is to find out how long JNJ-75348780 stays in and acts on the body and how the body responds to it. There is only preliminary safety information available on the use of JNJ-75348780 in humans; therefore, administration of JNJ-75348780 may involve risks that are currently not known. Patients will be provided study drug as long as they receive benefit from the drug.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    20/WM/0306

  • Date of REC Opinion

    7 Jan 2021

  • REC opinion

    Further Information Favourable Opinion