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global@GCP-ClinPlus.com
For International Sponsors – Powered by GCP ClinPlus
In China, CGT IITs are investigator-initiated trials typically conducted at leading hospitals. They are often used for early-stage exploration of new indications or treatment regimens using stem cells, CAR-T, or other CGT products. These trials fall under the regulatory purview of the National Health Commission (NHC) and local ethics committees, not the NMPA (drug authority), although data can later support NMPA IND filings.
Yes. While most IITs in China focus on marketed drugs, CGT IITs are an exception due to unmet medical needs and urgent clinical demand. This includes:
CAR-T for relapsed/refractory cancers
Stem cells for degenerative or autoimmune diseases
These are governed by special regulations such as the Stem Cell Clinical Research Guidelines (Trial) and Technical Guidance for Immune Cell Therapy Clinical Trials.
Faster early-phase clinical data from real-world settings
Lower costs compared to global Phase I/II studies
Opportunity to generate pre-IND safety/efficacy data
Access to large patient populations for rare or advanced diseases
Potential to shorten time to registration by 1.5 years
Key steps include:
Submit proposal via hospital CTMS
Scientific & ethical review
Approval by hospital's IIT office
MOH/NHC registration in the Medical Research Registry System
Human genetic resources filing (if applicable)
ClinicalTrials.gov registration
Only Tier 1 hospitals with specific credentials may host CGT IITs:
Must hold NHC certification for stem cell/immune cell therapy research.
Require on-site GMP-compliant cell processing facilities or contracted NMPA-licensed CDMOs.
Must demonstrate expertise in managing CGT-related risks (e.g., CRS, neurotoxicity).
Trials must have:
Institutional certification
Clear patient risk controls
Pre-defined stopping rules for severe adverse events
Yes. IIT data—especially long-term safety and early efficacy signals—can be used as:
Supporting evidence for IND submission
Design reference for pivotal trials
Bridging data for conditional approvals
Not necessarily. Foreign sponsors are no longer required to partner with a local biotech. However:
Using a local CDMO simplifies approvals
Working with an experienced CRO like GCP ClinPlus ensures quality, compliance, and site engagement
22+ years' experience, with 50+ CGT trials completed
Proven track record across CAR-T, stem cells, oncolytic virus, and gene therapy
Executed 19 IITs in China in diseases including glioblastoma, MM, NSCLC, HCC, β-thalassemia, ALS, and more
Deep relationships with top CGT investigators and elite hospitals
Full-service capabilities from protocol development to site management and data submission
More real-world data integration into regulatory filings
Regulatory upgrades to differentiate gene-editing vs. non-editing therapies
Increasing emphasis on ethics and long-term safety
IITs as a strategic path for market entry
Sponsor-owned IP: Default if sponsor funds the trial (defined in the hospital contract).
Joint IP: Possible for investigator-initiated discoveries; rights negotiated upfront.
Publication rights: Hospitals typically require manuscript review
Contact GCP ClinPlus for a feasibility consultation, hospital connection, or local regulatory assessment. We are ready to help international sponsors conduct high-quality, compliant, and efficient CGT IITs in China.
Email: suling.zhang@gcp-clinplus.com
Website: gcpclinplus.com
Locations: China (Beijing, Shanghai, Guangzhou & more), US