JNJ-68284528

Overview

JNJ-68284528 (LCAR-B38M) 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.

SparkCures ID 328
Developed By Janssen Research & Development
Generic Name JNJ-68284528
Additional Names LCAR-B38M
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

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Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Preliminary Data from a Phase 1b/2 clinical trial (CARTITUDE-1)

December 07, 2019

  • Treated patients (n=29) received a median of five prior lines of therapy.
  • The overall response rate (ORR) was 100% at a median follow-up of six months, including a 69% complete response rate.
  • 100% of evaluable patients achieved early minimal residual disease (MRD)-negative status at day 28 post-infusion.
  • At month 6, 93% (n=27/29) were progression-free.
  • On the safety front, the most common adverse events were cytokine release syndrome (CRS) (93%) (most mild or moderate), neutropenia (93%), anemia (86%) and thrombocytopenia (86%). The most common serious/life-threatening/fatal adverse events were neutropenia (93%), thrombocytopenia (69%) and anemia (55%). One participant died of CRS complications at day 99. Median onset of CRS was seven days post-infusion with a median duration of four days.
  • A dose of 0.75x10CAR+ viable T cells/kg will be used in the Phase 2 portion.
  • The company says JNJ-4528 is a structurally differentiated CAR T with two BCMA-targeting single domain antibodies.

Dr Deepu Madduri & Ash

Resources