CARsgen's Allogeneic CD38 CAR-T Therapy: A Promising Step Towards Off-the-Shelf Cancer Treatments

CARsgen Therapeutics Holdings Limited, a biopharmaceutical company focused on innovative CAR T-cell therapies, has announced the administration of the first dose in an investigator-initiated trial for its allogeneic CD38 CAR-T therapy, KJ-C2320. This marks a significant milestone in the development of off-the-shelf cancer treatments, which have the potential to revolutionize the way we approach cancer care.



Allogeneic CAR-T therapies, such as KJ-C2320, offer several advantages over autologous therapies. One of the most notable benefits is the ability to manufacture and store a large number of off-the-shelf products, which can significantly reduce the time required for treatment initiation. This is particularly important in emergency situations where time is of the essence. Additionally, allogeneic therapies can be produced at a lower cost than autologous therapies, making them more accessible to a larger patient population. Furthermore, allogeneic therapies can be used to treat patients who do not have enough T cells to produce an autologous product, such as those with advanced cancer or those who have undergone chemotherapy. Lastly, allogeneic therapies can be used to treat patients who have relapsed after autologous therapy, providing an additional treatment option for these patients.



The THANK-uCAR® platform developed by CARsgen Therapeutics addresses several challenges of allogeneic CAR-T therapies by incorporating innovative modifications to donor-derived T cells. The platform minimizes the risk of Graft vs. Host Disease (GvHD) and Host vs. Graft Response (HvGR) by disrupting the genomic loci encoding the T-cell receptor (TCR) and beta-2 microglobulin (B2M). This eliminates surface expression of the TCR and human leukocyte antigen class I (HLA-I), reducing the risk of GvHD and HvGR. Additionally, the platform protects the allogeneic CAR-T cells from rejection by the patient's natural killer (NK) cells by arming the TCR-/B2M- T cells with a CAR that recognizes NKG2A. This hinders the NKG2A-positive NK cell rejection of the CAR T cells, allowing the THANK-uCAR-T cells to resist the attack by NK cells. Clinical studies have demonstrated that the BCMA CAR-T therapy developed on the THANK-uCAR® platform can expand in patients, achieving complete response levels comparable to autologous CAR-T, showing preliminary evidence of controllable safety and promising efficacy.



The investigator-initiated trial for KJ-C2320 is ongoing in China and aims to evaluate the therapy for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML). While the specific timeline for the completion of this trial and potential regulatory submissions has not been explicitly stated, the administration of the first dose marks a significant step forward in the development of this promising therapy.

In conclusion, CARsgen's allogeneic CD38 CAR-T therapy, KJ-C2320, has the potential to revolutionize cancer care by offering a more accessible and effective treatment option for patients with relapsed/refractory acute myeloid leukemia. The THANK-uCAR® platform addresses several challenges of allogeneic CAR-T therapies, making this therapy a promising step towards off-the-shelf cancer treatments. As the trial progresses, we eagerly await the results and potential regulatory submissions that could bring this innovative therapy to patients in need.