GCT3009-01, NHL, open-label GEN3009 dose escalation and expansion
Research type
Research Study
Full title
Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts
IRAS ID
291616
Contact name
Andrew Davies
Contact email
Sponsor organisation
Genmab Holding B.V.
Eudract number
2019-002752-16
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
145264, IND
Duration of Study in the UK
2 years, 7 months, 22 days
Research summary
This trial is a First in Human (FIH), open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics (the study of what the body does to the drug), pharmacodynamics (the study of what the drug does to the body), immunogenicity (the ability of a foreign substance to provoke an immune response in the body, especially the production of antibodies), and preliminary effectiveness of GEN3009 in participants with relapsed or refractory (R/R) B-cell Non-Hodgkin lymphoma (NHL).
The trial will be conducted in 2 parts; Dose Escalation and Expansion. In the Dose Escalation, GEN3009 will be administered by intravenous (IV) infusions at 7 dose levels ranging from 6 mg to 1200 mg in 4-week (28-day) cycles. Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle and the maximum tolerated dose (MTD) may be identified. The totality of the data including safety, pharmacokinetics, pharmacodynamics, and preliminary effectiveness will be evaluated to guide further development for Expansion, with additional participants treated with the recommended phase 2 dose (RP2D).
Up to 60 participants with R/R B-cell NHL, including chronic lymphocytic leukaemia (CLL) / Small lymphocytic lymphoma (SLL), will be enrolled in the Dose Escalation, and 60 participants with R/R Diffuse large B-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), R/R CLL will be enrolled in the Expansion. The UK will only participate in the Expansion.
Treatment should continue until the participant fulfils 1 of the treatment discontinuation criteria e.g. unacceptable Adverse Events (AEs), participant non-compliance, Sponsor decision, pregnancy, participant request to discontinue treatment, clinical progression, disease progression according to response criteria.
The trial is considered completed when the last participant dies or withdraws from the trial. The maximum trial duration is 5 years after the last participant’s first treatment.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0075
Date of REC Opinion
8 Mar 2021
REC opinion
Further Information Favourable Opinion