October 31, 2019
- China regulators have cleared the IND for the fully human BCMA CAR-T, CT-103A, in development by Nanjing Iaso and Innovent Biologics.
- In the recent issue of BioWorld (pages 1 & 6), Brian Hall, VP of Business Development at Iaso, stated that a phase 1b/2 trial to confirm the recommended phase 2 dose is planned to start 1Q20 and will enroll 60-70 patients. Hall also notes a CT-103A approval is planned in 2H21.
- In the investigator-initiated trial at Tongji Hospital, CT-103A treatment led to an ORR of 100% (sCR: 71%, CR: 88%) and four patients who relapsed on a previous murine BCMA CAR-T therapy have all achieved > VGPR. Onset of CRS occurred within 2-5 days and resolved within two weeks.