Chinese biopharmaceutical company CARsgen Therapeutics Holdings Limited (HK:2171), a developer of CAR T-cell therapies, announced on Sunday preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T developed using CARsgen's THANK-u Plus platform.

CT0596 is currently being evaluated in an early exploratory clinical study for relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukaemia (R/R PCL) to assess its safety and preliminary efficacy.

As of 6 May 2025, eight patients with R/R MM who had received at least three prior lines of therapy were enrolled and infused with CT0596 following lymphodepletion with the FC regimen (fludarabine 22.5-30 mg/m2 and cyclophosphamide 350-500 mg/m2).

The company reported that based on the preliminary safety and efficacy data, CT0596 demonstrated favourable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed. It added that these findings warrant further exploration not only in R/R MM, but also in other plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells.

CARsgen intends to present detailed clinical data at upcoming scientific conferences. The company anticipates submitting an Investigational New Drug application for this product candidate in the second half of 2025.