CARsgen Initiates Trial for Allogeneic CD19/CD20 CAR-T Therapy: A Step Towards Off-the-Shelf Cancer Treatment

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a leading biopharmaceutical company focused on innovative CAR T-cell therapies, has announced the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy targeting CD19/CD20. This trial marks a significant milestone in the development of off-the-shelf cancer treatments, potentially revolutionizing the way patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) are treated.

KJ-C2219 is developed based on CARsgen's THANK-u Plus platform, an enhanced version of its proprietary THANK-uCAR® allogeneic CAR-T technology. The THANK-u Plus platform addresses the potential impact of NKG2A expression levels on therapeutic efficacy, ensuring sustained expansion of CAR-T cells regardless of varying NKG2A expression levels on NK cells. Preclinical studies have shown that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR®, with allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibiting robust antitumor activity in the presence of NK cells.

The IIT will evaluate KJ-C2219 for the treatment of R/R B-NHL, with the primary endpoint being the overall response rate (ORR) and the secondary endpoints including the duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The trial is expected to enroll approximately 30 patients, who will be randomly assigned to receive either KJ-C2219 or the physician's choice of treatment (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab).