I’m Pedro Silva Couto, and this blog combines content from my personal blog, Cell and Gene Therapy Today, together with data from my membership on the team at CellTrials.org.
Recent clinical trials of note within the cell and gene therapy space
NCT06682793 was posted on ClinicalTrials.gov by A2 Biotherapeutics, a California-based company that has a proprietary logic-gated TmodTM platform that enables allogeneic CAR-T therapies to integrate multiple signals which distinguish tumor cells from normal cells. They have launched a phase 1/2 multi-center trial of their product A2B395. This trial will recruit patients that are HLA-A*02 heterozygous and have been diagnosed with a variety of advanced solid tumors that both express EGFR and have Lost HLA-A*02 expression. The product A2B395 will be administered as a single intravenous dose.
NCT06688435 was posted on ClinicalTrials.gov by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. The CSPC Pharmaceutical Group is a China-based manufacturer of drugs that is traded on the Hong Kong stock exchange. World Brand Lab has ranked CSPC among the "Top 500 Most Valuable Brands in China" for more than ten years since 2004. In this new phase 1 trial, CSPC is testing a CAR-T therapy product called SYS6020 against the auto-immune disease Myasthenia Gravis. Their CAR-T product targets the BCMA receptor, similar to the FDA-approved products Abecma (Bristol-Myers Squibb) and Carvykti (Janssen Biotech). The novelty of clinical trial NCT06688435 is that lipid nanoparticles are employed to deliver mRNA encoding for the CAR-T targeting of BCMA, unlike the previously approved products which use a viral vector to encode the CAR-T target. The trial NCT06688435 is designed to dose escalate the autologous CAR-T cells, recruiting 50 patients onto five arms that test the number of cells per dose and the number of doses.
NCT06691308 was posted on ClinicalTrials.gov by Beijing Immunochina Medical Science & Technology Co., Ltd. This company, also known as Immunochina Pharmaceuticals, focuses on CAR-T products and has seven INDs in China. The phase 1 trial NCT06691308 is a study of the product WL276, a CAR-T therapy which targets CD276 positive glioblastoma and is given by local intracranial administration using the Ommaya reservoir device. The study will recruit six patients on two dosage arms of 5 or 10 million cells.