On April 3, 2020 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell & gene therapy company, is reported that China National Medical Products Administration (NMPA) has accepted Gracell’s Investigational New Drug (IND) application for GC007g, a donor-derived anti-CD19 chimeric antigen receptor (CAR-T) cell therapy (Press release, Gracell Biotechnologies, APR 3, 2020, View Source [SID1234556125]).

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GC007g is an allogenic CAR-T therapy under development for B-ALL patients who relapsed or refractory from prior treatment. The therapy utilizes healthy T cells from human leukocyte antigens (HLA) matching donors, with potentially better T cell fitness, and possibly higher efficacy compared to the use of patient’s own T cells. The company plans to initiate a phase 1 clinical study in patients with CD19 positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) in Q2, 2020.

"The IND approval for GC007g marks a significant milestone for Gracell." said Dr. William CAO, founder and CEO of Gracell, "We are delighted that this first-of-its-kind CAR-T program will soon be evaluated in IND approved clinical trials. We expect donor-derived CAR-T therapy, GC007g may become a good alternative solution to the r/r B-ALL patients who may not be eligible for autologous CAR-T therapy due to infections and other conditions, to those who do not respond to autologous CAR-T therapy, or to those whose CAR-T cells fail to be manufactured successfully".

About GC007g
GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA matching donors’ T cells were employed to redirected to eradicate CD19 positive leukemia cells.

About B-ALL
B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 501. In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide2. It is also the most common cause of cancer and death from cancer among children. First onset ALL is typically treated with long term chemotherapy. In case of relapsed or refractory disease immunotherapy monoclonal antibodies may be an option in certain subtypes while CART therapy may be an option for patients 25 and younger.