ASH2024 | Bioheng Therapeutics to Present Latest Clinical Data of RD13-02 for Treating R/R T-ALL/LBL Patients in Oral Presentation
Release Time:
2024-11-07
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Bioheng
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November 7, 2024, Bioheng Therapeutics (referred to as "Bioheng"), an innovative biopharmaceutical company dedicated to the development and commercialization of cell therapy products, announced today that it will present the latest Phase I clinical data of its universal CAR-T cell product RD13-02, targeting CD7 for the treatment of relapsed/refractory(R/R) T-ALL/LBL patients, in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting. The conference will take place from December 7-10, 2024, in San Diego, USA.
Presentation title: A Novel Generation of Anti-CD7 Universal CAR-T Therapy for Patients with Relapsed or Refractory CD7 Positive T-ALL/LBL: A Phase I Clinical Trial
Abstract Number: 921
Presentation Time: Monday, December 9, 2024 at 3:15 p.m. Pacific Time
Presentation location: San Diego Convention Center, Hall B
About RD13-02
RD13-02 is a universal CAR-T cell product targeting CD7 derived from healthy donors, and intended for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (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. RD13-02 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.
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June 1, 2025 , Bioheng Therapeutics, an innovative biopharmaceutical company focused on the development and commercialization of cell therapies, presented results from an investigator-initiated trial (IIT) of RD06-03, its allogeneic anti-CD19 CAR-T therapy for relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
February 28, 2025 – Bioheng Therapeutics US LLC (“Bioheng”), a clinical-stage biopharmaceutical 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.
November 7, 2024, Bioheng Therapeutics (referred to as "Bioheng"), an innovative biopharmaceutical company dedicated to the development and commercialization of cell therapy products, announced today that it will present the latest Phase I clinical data of its universal CAR-T cell product RD13-02, targeting CD7 for the treatment of relapsed/refractory(R/R) T-ALL/LBL patients, in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting. The conference will take place from December 7-10, 2024, in San Diego, USA.
On May 16, 2024, Bioheng Therapeutics (referred to as "Bioheng"), an innovative biopharmaceutical company focusing on the development and commercialization of Universal Chimeric Antigen Receptor T-cell (UCAR-T) products, announced today that it will present the Phase I clinical data of its CD7-targeted Universal CAR-T cell product, RD13-02, for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) patients at the 29th European Hematology Association (EHA 2024) Annual Congress, to be held in Madrid, Spain, from June 13 to 16, 2024, in the form of an academic poster.
On April 25, 2024, The New England Journal of Medicine published the latest findings by the team of He Huang, M.D., PhD., and Yongxian Hu, M.D., PhD., from the First Affiliated Hospital, Zhejiang University School of Medicine, titled "Sequential CD7 CAR-T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis"[1]. The study introduces an innovative treatment strategy that combines CD7 CAR-T with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the first time.
Bioheng Received CDE IND Approval for CTA101 UCAR-T
On March 17,2022, China National Drug Administration Drug Review Center ( CDE ) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug ( Acceptance No. : CXSL2101509 ) . CTA101 is independently developed by Nanjing Bioheng Biotech Co., Ltd ( hereinafter referred as ' Bioheng), targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ).
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