Scheduled to begin enrollment in the second half of 2018, the Phase 1b/2 study (68284528MMY2001) is part of a collaboration between Legend Biotech and Janssen that was formed in December 2017 to develop CAR-T therapy for MM globally.
 

LCAR-B38M (JNJ-68284528) is an autologous CAR-T therapy that targets B cell Maturation Antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells.  The investigational therapy expresses an identical CAR protein as Legend’s LCAR-B38M CAR-T product, which was evaluated in a first-in-human clinical study (Legend-2) conducted in multiple sites by Legend Biotech in China.

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 Legend-2 first-in-human study. 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).

“This is a very exciting moment, as we celebrate the achievement of this critical milestone with our strategic partner Janssen,” said Dr. Frank Zhang, chairman and chief executive officer of GenScript Biotech Corporation.  “We are very pleased with the pace of progress already achieved through the diligent efforts of the Janssen and Legend teams, reflecting our goal of bringing this important therapeutic option to patients as soon as possible.”
 

“This milestone demonstrates tremendous progress, achieved within six months of establishing our development partnership with Janssen, and reflects the productive and collaborative relationship formed between the teams at both organizations that are working to bring this program forward swiftly,” said Dr. Yuan Xu, chief executive officer of Legend Biotech.