ICT Announces FDA Clearance for Phase I Clinical Trial of Next-Generation Armored CAR-T Therapy ICTCAR014 Targeting Relapsed/Refractory Non-Hodgkin Lymphoma

On December 5, 2019, VCBeat learned that ICT Biotechnology Co., Ltd. (ICT) is a biotech company with a multi-technology, multi-product-line CAR-T cell therapy development platform, dedicated to developing CAR-T cell therapies for hematologic malignancies and solid tumors.

ICT Biotechnology Co., Ltd. (ICT) announced that its next-generation “armored” CAR-T product, ICTCAR014—which targets CD19 and expresses a dominant negative PD-1 molecule to block tumor immunosuppressive pathways—has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). In 2020, ICT will begin enrolling patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) whose tumor cells express PD-L1 on their surface for the ICTCAR014 clinical trial in the United States. Dr. David L. Porter from the University of Pennsylvania will serve as the principal investigator for this clinical trial.

 

In response, Dr. Xiao Lei, Founder and CEO of ICT, stated, “Obtaining approval from the U.S. FDA to conduct clinical trials is a significant milestone, representing another solid step forward in our journey of technological innovation. At the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November, we announced the clinical results of ICTCAR014, which demonstrated an overall response rate (ORR) of 92%. These clinical findings indicate that the product features both low risk and a high response rate. Our corporate strategy is grounded in clinical efficacy, aiming to translate our innovative technologies into multiple global projects and further expand our worldwide market presence through regulatory approvals. We eagerly anticipate the initiation of the first clinical trial of ICTCAR014 in the United States.”

 

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About ICTCAR014

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ICTCAR014, a next-generation “armored” CAR-T product. ICTCAR014 is a CD19-targeted CAR-T therapy designed for relapsed/refractory non-Hodgkin lymphoma (r/r NHL). It expresses dominant-negative PD-1 on the surface of CAR-T cells to block tumor-mediated immunosuppressive pathways, thereby enhancing CAR-T cell functionality—hence the designation as “armored” CAR-T cells. This cellular therapy for r/r NHL has already demonstrated remarkable efficacy in clinical practice.

At the Society for Immunotherapy of Cancer (SITC) Annual Meeting this November, ICT presented clinical data for this product. As of November 2019, among 13 evaluable patients with non-Hodgkin lymphoma (NHL), the overall response rate (ORR) was as high as 92.3%, the complete response rate (CR) reached 53.8%, and the partial response rate (PR) was 38.5%. This therapy has demonstrated significant objective tumor responses in current clinical observations, with low and manageable toxicity-related adverse events during treatment.

 

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About Shanghai ICT

Shanghai Si Dan Race BioTechnology Co., Ltd. (ICT) is a company dedicated to the research and development of innovative CAR-T cell therapies for hematologic malignancies and solid tumors. Currently, ICT has achieved remarkable preclinical and clinical outcomes using cutting-edge CAR-T technology in the treatment of advanced-stage lymphoma and leukemia. This year, ICT’s product ICTCAR014, targeting CD19 in non-Hodgkin lymphoma (NHL) and expressing Dominant Negative PD-1, received approval from the U.S. Food and Drug Administration (FDA) for clinical trials. Prior to this, its CD19-targeted product for B-cell acute leukemia received clinical trial approval from China’s Center for Drug Evaluation (CDE). Shanghai Si Dan Race BioTechnology Co., Ltd. (ICT) boasts a robust pipeline for solid tumors, with multiple innovative CAR-T technologies currently under development and in clinical trials.