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Gracell Biotechnologies Reports the US FDA Clearance of IND Application for GC012F to Treat Multiple Myeloma

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Gracell Biotechnologies

Gracell Biotechnologies Reports the US FDA Clearance of IND Application for GC012F to Treat Multiple Myeloma

Shots:

  • Following the IND clearance, Gracell expects to initiate a P-I clinical trial evaluating GC012F as an early-line treatment for patients with multiple myeloma across the US
  • Additionally, GC012F is also being evaluated in a P-Ib/II clinical trial for the treatment of r/r multiple myeloma & in an expected (initiation in 2024) P-I/II trial for the treatment of rSLE. GC012F is also being evaluated in 4 investigator-initiated trials for rSLE
  • According to the data presented at the ASH Annual Meeting 2023, GC012F depicted an ORR of 100% & minimum residual disease negative stringent CRR of 95.5%. GC012F is an autologous CAR-T therapy that targets BCMA & CD19 & leverages Gracell’s proprietary FasTCAR next-day manufacturing platform

Ref: Gracell Biotechnologies Image: Gracell Biotechnologies

Related News:- AstraZeneca to Acquire Gracell Biotechnologies for ~$1.2B

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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