We are a comprehensive Contract Research Organization providing full-services for global biopharmaceutical and medical apparatus enterprises, including clinical operations, regulatory affairs, medical strategy and writing, medical monitoring, data management and statistical analysis, pharmacovigilance and call center services, quality assurance and audit, marketing strategy, consulting and training services etc.
Since established in 2009, CSC has been actively engaged in global clinical research and academic communication in the medical field, and helping patients worldwide by providing clinical professional services for pharmaceutical companies, authoritative academic institutions, clinical trial research institutions, medical experts, doctors, etc.
Status:China: Phase II clinical trial is about to start; USA: Granted FDA orphan drug designation; EU: Granted orphan drug designation by the European Commission
Collaboration Opportunity: Licensing collaboration/co-development; investment and financing
Highlights:
The CD7-targeted CAR-T therapy has high technical barriers, with few companies currently positioned in this field, providing a significant competitive advantage.
Innovatively using a non-gene editing strategy and the nanobody VHH6, normal T lymphocytes from the patient's own peripheral blood are modified with CAR and then reinfused into the patient, avoiding the risk of GVHD.
Excellent Phase I clinical results: A total of 12 refractory relapsed patients were treated; significant antitumor efficacy was observed in all dose groups; ORR = 83%, CR = 75%, 3M DOR = 66.7%.