Gracell Biotechnologies Co., Ltd. announced the initiation of an investigational study of GC027, the first product candidate developed using TruUCAR to treat relapsed or refractory (R/R) T-cell malignancies. T-cell acute lymphoblastic leukemia or T-ALL is an aggressive form of ALL, which affects white blood cells and the bone marrows ability to generate healthy blood cells. About 15-20% of people with ALL have T-ALL. While T-ALL is treatable by chemotherapy and stem cell transplant, around 75% of patients will relapse within two years. T-cell lymphoblastic lymphoma (T-LBL) is another devastating T-cell malignancies. For patients who develop R/R T-ALL or T-LBL, there are few options for treatment. Autologus CAR-T therapies rely on patients' own T cells, which have been affected by prior therapies; thus, cell quality as well as efficacy remains questionable. Allogenic CAR-T therapies made of healthy donors' T cells would be characterized as being of consistently good quality with the potential to improve efficacy. Unlike autologous CAR-T cells, allogeneic CAR-T cells can be made as off-the-shelf product which means patients do not have to wait for lengthy production time. Furthermore, the cost of production can be significantly lower. Allogenic CAR-T therapies also provide a vital treatment option for patients with viral infections and/or other conditions prohibiting access to autologous cell therapies. TruUCAR based GC027 is designed to meet the above unmet needs. Its cells are made of T cells from healthy donors, genetically edited and inserted with chimeric antigen receptor (CAR) ex vivo, which can specifically bind to and eliminate target T malignant cells. Different from off-the-shelf CAR-T design, Gracell's proprietary and patented TruUCAR™ technology requires no co-administration of anti-CD52, a cytotoxic agent for ablating cancerous cells while inducing long term immune depletion in the patient. Instead, GC027 utilizes CRISPR genome editing strategy that is expected to avoid graft-versus-host disease (GvHD) as well as graft rejection caused by the patients' immune system. The prudent preclinical studies provide substantial evidence to trigger GC027 moving into a non-IND (investigational new drug) clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of GC027 therapy in patients suffering from relapsed and refractory T lymphocyte malignancies. TruUCAR is another technological breakthrough developed by Gracell following the recent announcement of FasTCAR technology and products. It enables producing off-the-shelf CAR-T cells from healthy MHC (major histocompatibility complex) mismatched donors with a large number of doses readily to be dispatched to patients in need.