Johnson & Johnson unit Janssen Pharmaceutical Companies is set to start a Phase Ib/II clinical trial to evaluate the safety and efficacy of JNJ-68284528 in patients with relapsed or refractory multiple myeloma.
The open-label, multicentre trial comes after FDA approved the company’s investigational new drug (IND) application.
Janssen expects to begin patient enrolment in the second half of this year.
The primary endpoint of the Phase Ib portion of the trial is to characterise the safety and establish the dose of JNJ-68284528.
The trial’s Phase II primary objective is to evaluate the efficacy of JNJ-68284528.
Other primary endpoints of the trial include overall response rate as defined by the International Myeloma Working Group response criteria.
Janssen research and development oncology global therapeutic area head Peter Lebowitz said: “As we strive to eliminate multiple myeloma, we are hopeful that this BCMA targeted CAR-T therapy will play an important role in the treatment of this disease.”
Last December, Janssen signed a collaboration and licence agreement with Legend Biotech USA and Legend Biotech Ireland for the joint development and commercialisation of JNJ-68284528 in multiple myeloma.
JNJ-68284528, a chimeric antigen receptor T cell (CAR-T) therapy directed against B cell maturation antigen (BCMA), was developed on the basis of Legend’s LCAR-B38M CAR-T cells platform.
CAR-T cells are a new approach to eliminate cancer cells by harnessing the power of a patient’s own immune system, while BCMA is a protein that is highly expressed on myeloma cells.
By targeting BCMA through a CAR-T approach, therapies could redefine the treatment scenario for multiple myeloma and could advance the development of cures for patients.