CAR T therapy to enter early testing in multiple myeloma

 

Janssen Biotech is launching a phase 1b/2 trial of an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed or refractory multiple myeloma.

The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

The goal of the phase 1b study will be to evaluate the safety of the therapy and establish the dose. In the phase 2 portion of the study, the primary endpoint is the overall response rate as defined by the International Myeloma Working Group response criteria.

The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.

mschneider@mdedge.com

 

Janssen Biotech is launching a phase 1b/2 trial of an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed or refractory multiple myeloma.

The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

The goal of the phase 1b study will be to evaluate the safety of the therapy and establish the dose. In the phase 2 portion of the study, the primary endpoint is the overall response rate as defined by the International Myeloma Working Group response criteria.

The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.

mschneider@mdedge.com

 

Janssen Biotech is launching a phase 1b/2 trial of an investigational chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed or refractory multiple myeloma.

The trial, which was cleared by the Food and Drug Administration to begin in the second half of 2018, will evaluate the safety and efficacy of LCAR-B38M (JNJ-68284528). The CAR T therapy targets B-cell Maturation Antigen and expresses a CAR protein that is identical to a product that was developed by Legend Biotech and evaluated in a first-in-human clinical study in China.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

The goal of the phase 1b study will be to evaluate the safety of the therapy and establish the dose. In the phase 2 portion of the study, the primary endpoint is the overall response rate as defined by the International Myeloma Working Group response criteria.

The drug is being developed as part of a collaboration between Legend Biotech and Janssen Biotech.

mschneider@mdedge.com