Recently, Bioheng Biotech announced that its universal CAR-T cell therapy CTD402 targeting CD7 has received the approval of a new drug clinical trial application (IND) from the U.S. Food and Drug Administration (FDA) for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II clinical trial using a simplified dose exploration design to optimize the dosing regimen and accelerate the clinical development process.
"We are delighted that CTD402 has received IND approval from the U.S. FDA, allowing us to proceed with a Phase Ib/II clinical trial utilizing a simplified dose-finding design, which will accelerate our clinical development process in the United States," said Dr. Jiangtao Ren, President and Chief Scientific Officer of Nanjing Bioheng Biotech Co., Ltd. "Data from investigator-initiated trials (IIT) have demonstrated encouraging objective response rates (ORR) and favorable safety profiles. These results validate the capability of our ANSWER® platform to achieve rapid therapeutic effects while reducing patient risks, positioning CTD402 as a potentially best-in-class treatment for T-cell malignancies."CTD402 is an allogeneic CAR-T (UCAR-T) cell therapy product targeting CD7 derived from healthy donors, intended for the treatment of T-ALL/LBL. This product avoids fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) through genetic modification while enhancing anti-tumor activity. CTD402 enables mass production in a single batch for multiple patients, providing an "off-the-shelf" solution for patients in need of CAR-T cell therapy.。About T-ALL/LBL
T-ALL and T-LBL are different clinical manifestations of the same malignant tumor, both originating from immature T-lineage lymphocytes, and are classified based on the extent of bone marrow involvement.。[1]Although first-line treatment can achieve a high complete response (CR) rate, most patients will eventually experience relapse. The prognosis for relapsed or refractory (R/R) disease is poor, with a 5-year overall survival (OS) rate of less than 20%.[2]Nanjing Bioheng Biotech Co., Ltd. is a clinical-stage company focused on the development of allogeneic "off-the-shelf" universal CAR-T therapies. Established in 2017, the company is committed to developing world-leading allogeneic cell therapy platforms and products to address significant unmet clinical needs in areas such as hematologic malignancies and autoimmune diseases.References
[1] Swerdlow S H, Campo E, Pileri S A, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms[J]. Blood, The Journal of the American Society of Hematology, 2016, 127(20): 2375-2390.
[2] Marks D I, Rowntree C. Management of adults with T-cell lymphoblastic leukemia[J]. Blood, The Journal of the American Society of Hematology, 2017, 129(9): 1134-1142.
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