Multiple myeloma - March 2021
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Multiple myeloma - March 2021
IASO Bio/Innovent’s CT103A granted BTD by the China's NMPA for the treatment of RRMM
22 Feb 2021
CT103A (BCMA-directed CAR T cell therapy) – IASO Biotherapeutics/ Innovent
- The BTD designation for CT103A is based on the results observed in ongoing Phase 1/2 study for the treatment of adults with relapsed or refractory multiple myeloma (RRMM)
- Trial details: ChiCTR1800018137; Phase 1 in recurrent/ refractory plasmacytoma; N= 20; CT103A IV Primary outcome: Safety; Recruiting; Location: China
- CT103A is currently in a Phase 2 pivotal trial for the treatment of adults with RRMM
- “We are thrilled to have been granted this important designation from NMPA. This reinforces the importance and robustness of CT103A as a new therapy option,” said IASO Bio founder and CEO Jinhua Zhang. “We anticipate an expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time”
BTD from China's NMPA will accelerate development of CT103A (Phase 2 pivotal study)
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CI Scientists Remarks:
- About the molecule: CT103A is a fully-human anti-BCMA targeted CAR-T cell therapy which uses lentivirus as a vector to transfect autologous T cells. CAR contains a fully-human scFv, CD8a hinge and transmembrane, 4-1BB-mediated co-stimulation, and CD3ζ activation domains
- In Sep’19, CT103A received IND approval from NMPA
- Results from Phase 1/2 study on which BTD was granted: As of May 22, 2019, 12 patients were enrolled
- ORR: 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in-vivo
- All patients (100%) experienced CRS. The onset of CRS occurred within 2-5 days (median-2.6) and resolved within 14 days
- Mostly grade 1 and 2, at the lowest dosage levels, CRS was routinely managed with tocilizumab and steroids
Parameter
Grade: n(%)
1
2
3
4
CRS
2(17)
6(50)
3(25)
1(8)
Bone marrow failure
1(8)
1(8)
Herpes Zoster
1(8)
Pulmonary infection
1(8)
1(8)
Pleuritis
1(8)
Hypoxemia
1(8)
– Dr. Kowndinya, CI Scientists