The planned start of the Phase 1b/2 study (68284528MMY2001), scheduled to begin enrollment in the second half of 2018, follows the US Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application submitted by Janssen.
As announced in December 2017, Janssen entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited (“Legend”), subsidiaries of GenScript Biotech Corporation.
Under the terms of the agreement, Legend granted Janssen Biotech, Inc. a worldwide license to jointly develop and commercialize JNJ-68284528 in multiple myeloma.
Janssen Research & Development Oncology global therapeutic area head Dr Peter Lebowitz said: “We are committed to rapidly advancing JNJ-68284528, and we are pleased to initiate a global clinical development program to further evaluate this cell-based therapy.
“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.”
The Phase 1b/2, open-label, multicenter study will evaluate the safety and efficacy of JNJ-68284528 in adults with relapsed or refractory multiple myeloma. The primary objective of the Phase 1b portion of the study is to characterize the safety and establish the dose of JNJ-68284528, which was informed by the first-in-human study with LCAR-B38M CAR-T cells (Legend-2).
The primary objective for the Phase 2 portion of the study is to evaluate the efficacy of JNJ-68284528 (primary endpoint: overall response rate [partial response or better] as defined by the International Myeloma Working Group response criteria).
CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells.
By targeting BCMA via a CAR-T approach, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.
Source: Company Press Release