REGN1979 in patients with relapsed or refractory non-Hodgkin lymphoma
Research type
Research Study
Full title
An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
IRAS ID
262118
Contact name
Hsiao-Chi Lo
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-002139-41
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
REGN1979 is an antibody (a type of protein) being studied for the treatment of follicular lymphoma. REGN1979 is an investigational drug, which means it has not been approved by any health authority for the treatment of follicular lymphoma.
The main purpose of this study is to assess the effectiveness of REGN1979 in destroying cancer cells and to learn more about the safety of REGN1979.
This study will include about 112 participants at about 100 research centres in North America, Europe, Asia, and Australia.
Participation in this study may last up to 46 months (about 3 and ¾ years). This study consists of:
• A screening period of up to 28 days
• A treatment period of up to 98 weeks (about 23 months)
• A follow-up period of up to 96 weeks (about 22 months) after the completion of the study drug treatment period.If the participant’s follicular lymphoma initially responds to REGN1979, but their disease progresses later, participants might qualify to be re-treated with REGN1979 for up to an additional 98 weeks (about 23 months).
Participants will be given the study drug through a vein (IV infusion) according to the following schedule:
- Week 1 to Week 12: study drug will be given each week for 12 consecutive weeks.
- Week 14 to Week 98: study drug will be given every 2 weeks over an 84-week period (about 20 months).Participants will be given 3 different doses of REGN1979.
Informed consent must be obtained from each participant before any study-related tests or procedures are performed. At scheduled study visits, participants will visit the research centre where study assessments will take place e.g. physical exam, vital signs, ECG’s (recording of the heart), blood and urine tests, biopsies, body scans and questionnaires.
Side effects will be monitored throughout the study.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0231
Date of REC Opinion
14 Aug 2019
REC opinion
Further Information Favourable Opinion