Gamida Cell Receives the US FDA’s IND Clearance and Removal of Clinical Hold of GDA-201 for the Treatment of Follicular and Diffuse Large B Cell Lymphoma
Shots:
- The US FDA has cleared its IND application to initiate a P-I/II study of GDA-201 in patients with follicular & DLBCL in 2022
- In an investigator-sponsored P-I/II study in patients with r/r lymphoma, GDA-201 + rituximab showed significant clinical activity & the results from 19 patients with NHL showed 13 CR & 1 PR with ORR of 74% & CRR of 68%, m-DoR of 16mos. & OS (78%) @2yrs.
- In IS study, GDA-201 was well-tolerated with no dose-limiting toxicities in 19 patients with NHL & 16 with MM, no incidence of CRS, neurotoxic events, GvHD, or marrow aplasia were observed. GDA-201 uses the NAM technology platform to increase the no. & functionality of NK cells to direct tumor cell killing properties & ADCC
Ref: Businesswire | Image: Gamida Cell
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