A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
Research type
Research Study
Full title
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
IRAS ID
1007944
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Clinicaltrials.gov Identifier
Research summary
This is a first in human multicenter study being conducted by AbbVie Deutschland GmbH & Co. KG for those participants with relapsed/refractory (R/R) B-cell non-Hodgkin’s Lymphoma (NHL) (chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenstrom’s Macroglobulinemia (WM))
Non-Hodgkin’s Lymphoma is a type of blood cancers also known as hematological cancers. Lymphoma develops when white blood cells called lymphocytes grow out of control. Lymphocytes are part of the immune system, which helps to fight infection. There are different types of non-Hodgkin lymphoma depending on how the cells are affected and the cancer behaves.
The purpose of this study is to see if ABBV-525 the study drug, is safe and tolerable in participants with R/R NHL. The study aims to find out a safe and tolerable dose and schedule of ABBV-525, understand how much ABBV-525 is in the blood at specific times after dosing, to see whether ABBV-525 is effective in treating B-cell malignancies and to understand whether there are any changes to the way the participant’s heart beats when ABBV-525 is taken.
The study drug has been studied in laboratory animals, but it has not been studied in humans. ABBV-525 is a MALT1 inhibitor (MALT1i) being developed as a treatment for B-cell NHL. The MALT1 protein helps normal B cells grow. It has also been shown to help cancer cells live and grow. By inhibiting or “blocking” MALT1, ABBV-525 may kill the cancer cells or stop them from growing.All participants will receive ABBV-525 orally once daily.
The study will last about 64 months. The amount of time enrolled participants will be on study treatment or be followed up for health information as part of the study depends on how enrolled participants respond to and tolerate the study treatment.
Approximately 150 participants will take part in this world-wide study.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0190
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion