City of Regeneration's CAR-T therapy for HIV under clinical review in China

The Center for Drug Evaluation (CDE) website indicates the clinical filing for anti-HIV-1 chimeric antibody receptor (CAR)-T therapy by Shenzhen-based immunotherapy specialist City of Regeneration has been accepted for review at the National Medical Products Administration (NMPA). The potential cure for HIV/AIDS, developed by Sun Yat-sen University, can effectively induce the lysis of chimeric antigen receptor T cells (VC-CAR-T) of CD4 T lymphocytes infected with HIV-1, eliminating cells expressing HIV-1 Env.

City of Regeneration initiated a clinical study for its CAR-T therapy in HIV-1 in August 2017, the first of its kind worldwide, followed by 20+ clinical trials utilizing CAR-T therapy to remove HIV-1 latent pool. No adverse reactions occurred in the subjects, who were transfused with anti-HIV-1 CAR-T preparations according to the dose escalation design. The company obtained the patent to the technology in August 2019, and its “A vc-car molecule and its application in clearing HIV-1 infected cells” earned US patent protection in March this year.

City of Regeneration was founded in 2018 and has developed multiple therapies against relapsed and refractory leukemia and lymphoma, EBV-related nasopharyngeal carcinoma, gastric cancer, ovarian cancer, breast cancer and other solid tumors.


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