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AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma
The clearance covers C-CAR039, an anti-CD20/CD19 bispecific CAR-T, after early trials in China showed a 91.5% overall response rate.
On Sunday, August 16, 2026, AbelZeta Pharma announced FDA clearance of the IND application for C-CAR039, also known as Prizloncabtagene Autoleucel, an anti-CD20/CD19 bispecific CAR-T for relapsed or refractory Large B-cell Lymphoma.
In July 2026, AbelZeta regained all development, regulatory, manufacturing, and commercialization rights for C-CAR039, positioning the company to accelerate global development of the therapy.
Data from 48 patients in China demonstrated a 91.5% overall response rate and an 85.1% complete response rate, with median progression-free survival of 60.1 months at a median follow-up of 53.9 months.
"We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony Bizuo Liu, Chairman and Chief Executive Officer of AbelZeta, noting the therapy addresses unmet needs for relapsed CAR-T patients.
AbelZeta is working with the FDA to finalize protocols for third-line and second-line Large B-cell Lymphoma patients, while a registrational Phase II clinical trial for treatment-naïve patients in China remains ongoing.