{"id":18655,"date":"2025-03-05T16:40:42","date_gmt":"2025-03-05T09:40:42","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=18655"},"modified":"2025-03-05T16:40:42","modified_gmt":"2025-03-05T09:40:42","slug":"bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-all-lbl","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=18655","title":{"rendered":"Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL\/LBL"},"content":{"rendered":"

BOSTON<\/span><\/span>, March 5, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Bioheng Therapeutics US LLC (“Bioheng”), a clinical-stage biotech<\/span> company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, 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 trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development.\u00a0<\/p>\n

“We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib\/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States<\/span>,” stated Jiangtao Ren<\/span>, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng. “IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER\u00ae<\/sup> platform’s ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies.”\u00a0<\/p>\n

About CTD402<\/b>
CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL\/LBL. It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people, achieving an “off-the-shelf” capability for patients in need of CAR-T cell therapy.\u00a0<\/p>\n

About T-ALL\/LBL<\/b>
T-ALL\/LBL are distinct clinical presentations of the same malignancy, originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1]<\/sup> While frontline therapy achieves high complete remission (CR) rates, the majority of patients ultimately experience relapse. Relapsed or refractory (R\/R) disease is associated with poor outcomes, with a 5-year overall survival (OS) rate of less than 20%.[2]<\/sup>\u00a0<\/p>\n

About Bioheng<\/b>
Bioheng Therapeutics is a clinical-stage company focused on allogeneic “off-the-shelf ” universal CAR-T therapies. Founded in 2017, we aim to develop the world’s leading allogeneic cell therapy platforms and products to address some of the most challenging unmet needs.\u00a0<\/span><\/p>\n

References:<\/b>
[1]\u202fSwerdlow 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\u202fD 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.\u00a0<\/p>\n

\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

BOSTON<\/span><\/span>, March 5, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Bioheng Therapeutics US LLC (“Bioheng”), a clinical-stage biotech<\/span> company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, 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 trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development.\u00a0<\/p>\n

“We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib\/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States<\/span>,” stated Jiangtao Ren<\/span>, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng. “IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER\u00ae<\/sup> platform’s ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies.”\u00a0<\/p>\n

About CTD402<\/b>
CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL\/LBL. It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people, achieving an “off-the-shelf” capability for patients in need of CAR-T cell therapy.\u00a0<\/p>\n

About T-ALL\/LBL<\/b>
T-ALL\/LBL are distinct clinical presentations of the same malignancy, originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1]<\/sup> While frontline therapy achieves high complete remission (CR) rates, the majority of patients ultimately experience relapse. Relapsed or refractory (R\/R) disease is associated with poor outcomes, with a 5-year overall survival (OS) rate of less than 20%.[2]<\/sup>\u00a0<\/p>\n

About Bioheng<\/b>
Bioheng Therapeutics is a clinical-stage company focused on allogeneic “off-the-shelf ” universal CAR-T therapies. Founded in 2017, we aim to develop the world’s leading allogeneic cell therapy platforms and products to address some of the most challenging unmet needs.\u00a0<\/span><\/p>\n

References:<\/b>
[1]\u202fSwerdlow 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\u202fD 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.\u00a0<\/p>\n

\u00a0<\/p>\n

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