CytoMed completes dose level 1 of Phase I trial for cancer treatment.

CytoMed Therapeutics has completed dose level 1 for its first-in-human Phase I dose-escalation clinical trial for treating advanced cancers with CAR gamma delta T cells. The trial, known as the ANGELICA Trial, is evaluating the safety and tolerability of the treatment. The next dose level, 2, is scheduled to start in Q3 2025.

CytoMed Therapeutics Limited (NASDAQ: GDTC) has successfully completed dose level 1 of its first-in-human Phase I dose-escalation clinical trial, the ANGELICA Trial [1]. The trial, which evaluates the safety and tolerability of allogeneic NKG2DL-targeting chimeric antigen receptor-grafted (CAR) gamma delta T cells (CTM-N2D), has now entered its next phase, with dose level 2 scheduled to commence in the third quarter of 2025.

The ANGELICA Trial is designed to assess the efficacy of CTM-N2D in treating a basket of cancer indications, including advanced solid and hematological malignancies. Unlike traditional CAR-T therapies, which require the collection and modification of a patient's own T cells, CTM-N2D uses gamma delta T cells derived from healthy donors. These cells are expanded and modified to express CARs targeting NKG2DL, proteins commonly present in many cancers. This approach eliminates the need for donor-patient compatibility matching, potentially broadening patient accessibility and reducing production complexities [2].

The successful completion of dose level 1 marks a significant milestone for CytoMed, demonstrating acceptable initial safety for the treatment. However, it is important to note that this phase primarily focuses on establishing safety, and no efficacy data has been released at this stage. The trial will continue to follow a standard dose-escalation design to identify the maximum tolerated dose while monitoring for adverse events.

The ANGELICA Trial is part of CytoMed's broader effort to develop novel cell-based allogeneic immunotherapies for the treatment of various human cancers. The company was spun off from the Agency for Science, Technology and Research (A*STAR) in 2018 and is focused on harnessing its proprietary technologies to create affordable treatments for blood and solid cancers [1].

While the completion of dose level 1 is a positive step, investors should remain cognizant that further clinical trials and data are needed to fully assess the efficacy and safety of CTM-N2D. The company's forward-looking statements highlight potential risks and uncertainties, including the initiation, progress, and results of clinical trials and the ability to successfully develop and commercialize its product candidates [1].

References:
[1] https://www.globenewswire.com/news-release/2025/07/21/3118840/0/en/Update-On-Clinical-Trial-Milestone-CytoMed-Therapeutics-Achieves-Completion-of-Dose-Level-1-of-its-ANGELICA-TRIAL-and-Proceeding-to-Dose-Level-2-in-Patients-with-Advanced-Solid-Tum.html
[2] https://www.stocktitan.net/news/GDTC/update-on-clinical-trial-milestone-cyto-med-therapeutics-achieves-ofe4ryeoisuu.html