Genxi Biotechnology Group (NASDAQ: GRCL; referred to as "Genxi Bio"), a global clinical-stage biopharmaceutical company dedicated to the development of efficient and economical cell therapy for cancer treatment, announced its use in the treatment of acute B-cell lymph.
The phase I/II registered clinical study of the donor-derived allogeneic, anti-CD19 chimeric antigen receptor (CAR)-T cell therapy GC007g for cell leukemia (B-ALL) completed the first patient enrollment
GC007g is a donor-derived allogeneic CAR-T cell therapy that uses human leukocyte antigen (HLA) matched donor T cells
Previously, China's National Medical Products Administration had approved Genxi Biologics to carry out a new drug clinical trial application (IND) for the treatment of B-ALL with GC007g, and in December 2020, it again approved Genxi Biologics to carry out Phase I/II registered clinical studies
This open, single-arm Phase I/II registration study aims to evaluate the safety and effectiveness of GC007g in the treatment of patients with relapsed/refractory B-ALL
"We are pleased to announce that the registered Phase I/II trial of the CAR-T therapy GC007g targeting CD19, which is used to treat B-ALL patients with donor-derived allogeneic genes, has successfully recruited the first patient into the group.
" Chief Medical Officer Dr.
Martina Sersch said, “GC007g is a unique treatment that is suitable for B-ALL patients who
have relapsed after allogeneic stem cell transplantation and do not meet the standard treatment conditions .
Genxi Bio has innovative products under development.
Combination, we look forward to continuously bringing more breakthrough CAR-T therapies to patients to solve more clinical unmet needs
Professor Zhang Xi from the Hematology Medical Center of Chongqing Xinqiao Hospital (Second Affiliated Hospital of the Army Military Medical University), the principal investigator of the GC007g clinical study, said: “In terms of the current clinical situation, B-ALL that has relapsed after allotransplantation has been received in the past.
Patients may not be able to receive autologous CAR-T cell therapy due to poor health and activity of their own cells, or due to infections and other conditions
Genxi Bio's unique GC007g donor-derived allogeneic CAR-T cell therapy will bring this to these patients New treatment options are expected to allow them to achieve remission again
I look forward to the positive progress of this research and benefit more patients as soon as possible
" At present, the team of Professor Zhang Xi and Gao Lei of Chongqing Xinqiao Hospital has successfully enrolled the first case.
Subject: The clinical trial is also being carried out simultaneously in the First Affiliated Hospital of Zhejiang University School of Medicine, under the responsibility of a team led by Professor Huang He