GEN3013 for relapsed B-cell Lymphoma
Research type
Research Study
Full title
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma
IRAS ID
241053
Contact name
Lene Ejstrup Soerensen
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2017-001748-36
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Malignant lymphoma (a cancer of a type of blood cells) is a disease characterized by malignant transformation of the cells from lymphoid tissue. Malignant lymphoma usually originates from B cells (a type of white blood cell of the lymphocyte subtype).
This study is being conducted to find out if GEN3013 (study drug) is safe and tolerable in participants with different types of lymphoma. This is a first-in-human clinical trial, which means the investigational drug, GEN3013, is being tested in humans for the first time.
GEN3013 is an antibody, that can target antigens (molecules on the surface of cells). GEN3013 is a bispecific antibody developed to direct healthy immune cells to fight against the lymphoma cells and destroy them.
GEN3013 will be given in cycles of 28 days. Participants will be offered continuing treatment until their disease is progressing or they have unacceptable side effects, or withdraw their consent.
This is a multicentre trial to be conducted in Europe and North America at around 10 centres in 58 participants.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0303
Date of REC Opinion
24 Sep 2018
REC opinion
Further Information Favourable Opinion