Cell & Gene Therapy (CGT)

GCP ClinPlus offers end-to-end CGT clinical development services aligned with global regulatory standards. We have supported 80+ CGT programs, including 40+ in oncology, rare diseases, autoimmune conditions, and regenerative medicine.

Our expertise spans cutting-edge modalities such as CAR-T (targeting BCMA, CD19, etc.), stem cell therapies, and gene therapies using viral vectors (e.g., lentivirus, AAV). Key indications include hematologic and solid tumors, aGVHD, β-thalassemia, retinal diseases, and immune disorders.

We provide full-process risk control with graded SOPs managing CRS/ICANS toxicity—covering tumor burden assessment before infusion, 24/7 multidisciplinary monitoring during treatment, and dynamic cytokine surveillance post-infusion.

Our in-house digital platform enables daily/weekly review and generates FDA/EMA-compliant statistical outputs, reducing data analysis time by up to 30%.

With a global perspective, our dual China–US regulatory teams ensure synchronized submissions and GLP-compliant sample management across international trial sites. Our strong KOL network and 160+ partner sites further ensure rapid startup and quality delivery.

From early-phase studies to pivotal trials, we deliver customized, efficient solutions to accelerate CGT innovation and market entry.