In a Phase II trial, CNCT19 offered increased efficacy levels and lasting remissions in relapsed/refractory B-cell acute lymphoblastic leukaemia patients. Credit: CDC / Unsplash.

The China National Medical Products Administration (NMPA) has accepted CASI Pharmaceuticals’ partner Juventas Cell Therapy’s new drug application (NDA) of CNCT19 (Inaticabtagene Autoleucel) to treat relapsed/refractory B-cell acute lymphoblastic leukaemia (r/r B-ALL) in adults.

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19.

According to the findings, CNCT19 offered increased efficacy levels, lasting remissions and significantly lowered reduced CAR-T-associated toxicity in r/r B-ALL patients. 

CNCT19 attained exceptional objective response rates (ORRs) with increased MRD-negative complete remission rates in trial subjects within three months and by the end of the third month, respectively. 

In the trial, 82.1% of the subjects attained complete remission with incomplete count recovery (CR/Cri) within three months, and 25 subjects were reported to be CR/CRi by the end of the third month. 

Cytokine release syndrome and neurotoxicity were reported to be the most prevalent adverse events (AEs) linked to CNCT19.

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CNCT19 is an investigational CAR-T cell therapy targeting CD-19.

In the registrational trial, the therapy showed a complete success rate of drug production in r/r B-ALL patients.

The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE).

CASI chairman and CEO Dr Wei-Wu He said: “CNCT19 NDA acceptance by NMPA represents a significant milestone. 

“We are in preparation for the anticipated CNCT-19 commercial launch. This product is truly exciting as it proved to have significant clinical benefits for unmet medical needs. 

“CASI and Juventas will work side-by-side to deliver CNCT19 to patients in China and eventually worldwide.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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