Micrograph showing myeloma cast nephropathy in a kidney biopsy. Credit: Nephron/

Gracell Biotechnologies has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to commence a Phase Ib/II clinical trial of GC012F to treat relapsed/refractory multiple myeloma (RRMM).

The company intends to commence the Phase Ib/II trial in the US in the second quarter of this year.

The Phase Ib part of the clinical trial has been designed for assessing GC012F’s tolerability and safety in RRMM patients.

It will also determine the recommended GC012F dose for the Phase II portion of the trial and characterise GC012F’s pharmacokinetics in RRMM patients.

The trial’s Phase II part will assess GC012F’s efficacy in RRMM patients and further characterise its safety.

An autologous CAR-T therapeutic candidate, GC012F simultaneously targets the CD19 and the B cell maturation antigen (BCMA). It uses the FasTCAR next-day manufacturing platform of the company.

Gracell Biotechnologies founder, chairman, and CEO Dr. William (Wei) Cao said: “Advancing our lead therapeutic candidate into a US clinical trial is major milestone for Gracell, and further validates our GC012F programme, proprietary FasTCAR next-day manufacturing platform, and novel dual-targeting approach.

“Having demonstrated deep responses and a favourable safety profile across indications, GC012F continues showing strong potential to become a transformative therapy.

“We look forward to initiating the Phase Ib/II clinical trial and to bringing this promising therapeutic candidate one step closer to patients in need.”

Currently, GC012F’s efficacy and safety are being assessed in multiple investigator-initiated trials (IIT) for the treatment of newly detected multiple myeloma, RRMM, and B-cell non-Hodgkin’s lymphoma.

It received Orphan Drug Designation from the FDA to treat multiple myeloma in November 2021.

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