Orvacabtagene autoleucel

Unassigned

New Medicines

Relapsed or refractory multiple myeloma (MM) - fourth-line or greater

Information

Advanced therapy medicinal product (ATMP)
Celgene
Celgene

Development and Regulatory status

None
None
Phase II Clinical Trials

Category

B-cell maturation antigen (BCMA) targeting chimeric antigen receptor T cell (CAR-T) therapy
The incidence in Europe is 4.5-6.0 per 100,000/year with a mortality rate of 4.1 per 100,000/year [1].
Relapsed or refractory multiple myeloma (MM) - fourth-line or greater
Intravenous

Trial or other data

Jan 20 · PI/II EVOLVE study is recruiting [2].
Feb 18 · PI/II EVOLVE study to determine the safety and efficacy of JCARH125 in adult subjects with relapsed and/or refractory multiple myeloma starts (NCT03430011). The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. 200 adults will be recruited in. Collection of primary outcome data (including overall response rate) is expected to complete Mar 21 [2].