China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use in treating recurrent/refractory (R/R) multiple myeloma (MM) and lymphoma.
Design and Findings of the Phase I Study
The Phase I study (NCT04818372) is designed to assess the safety and initial efficacy of CM313 in patients with R/R MM and R/R lymphoma, including Waldenström macroglobulinemia (WM) and marginal zone lymphoma (MZL). As of October 10, 2022, 34 patients were enrolled in the study, with 31 having R/R MM and 3 having MZL. The safety assessment indicates that CM313 is well-tolerated, with the dose successfully escalated to 16.0 mg/kg without reaching the maximum tolerable dose or encountering dose-limiting toxicity. The most common drug-related adverse events are infusion-related reactions and decreases in lymphocyte, white blood cell, and neutrophil counts, all of which are grade 1 or 2 and occurred during the first two medication sessions.
Efficacy Evaluation and Future Prospects
Of the 29 R/R MM patients who underwent at least one post-baseline efficacy evaluation, an overall objective response rate (ORR) of 34.5% was observed, with a median progression-free survival (PFS) of 132 days. The median overall survival (OS) has not been achieved. The Phase I study results suggest that CM313 demonstrates good overall safety and shows preliminary efficacy in treating R/R MM at a dose level of ≥ 2.0 mg/kg, indicating potential as a treatment option for patients with these conditions.-Fineline Info & Tech
