FDA OKs Study of Novel CAR-T Cell Therapy for Myeloma

The Food and Drug Administration (FDA) granted an investigational new drug application and the OK to proceed a phase 1b/2 clinical trial of GC012F, a CAR-T cell therapy used to treat patients with relapsed or refractory multiple myeloma, according to Gracell Biotechnologies, the manufacturer of the drug.

GC012F targets the BCMA and CD19 proteins, to find and attack cancer cells. The drug utilizes the FasTCAR processing platform, which speeds up the manufacturing of the CAR-T cell therapy — something that can traditionally take weeks.

READ MORE: What Is CAR-T Cell Therapy, and What Can Patients With Cancer Expect?

Prior research showed that 100% patients with relapsed or refractory myeloma who were treated with GC012F had minimal residual disease (MRD) negativity, meaning that after patients were treated, follow-up showed no detectable traces of disease.

The drug will be further evaluated later this year in a phase 1b/2 clinical trial. The phase 1b part will evaluate the safety and tolerability of GC012F for patients with relapsed or refractory multiple myeloma, while the phase 2 part of the study will evaluate how well the drug fights cancer, as well as continue evaluating the safety.

GC012F is also being studied in patients with non-Hodgkin lymphoma.

"Having demonstrated deep responses and a favorable safety profile across indications, GC012F continues showing strong potential to become a transformative therapy. We look forward to initiating the Phase 1b/2 clinical trial and to bringing this promising therapeutic candidate one step closer to patients in need,” Dr. William (Wei) Cao, founder, chairman and CEO of Gracell Therapeutics, said in a press release.

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