Investigator-Initiated Trials (IIT) in China

Investigator Initiated Trial Service for Cell and Gene Therapy

Your Gateway to CGT Clinical Translation — Powered by Cytoart

At Cytoart, Inc., we specialize in supporting Investigator-Initiated Trials (IITs) for Cell and Gene Therapy (CGT) — with a dedicated focus on China.

In China, IITs have become a strategic engine for early clinical validation, real-world exploration, and regulatory readiness in the CGT space. With the right local partner, biotech innovators can access patient populations, experienced investigators, and trial infrastructure — without the cost and delay of a full IND.

We help you unlock this opportunity.

 Why China for CGT IITs?

China offers unique advantages for cell and gene therapy development:

  • Hospital-based IITs can be launched without full IND filing — accelerating first-in-human validation

  • Leading academic centers have in-house GMP capacity and experienced investigators in CAR-T, TCR-T, NK, and gene editing

  • Favorable policy environment for innovative therapies under NMPA’s evolving framework

  • Large, treatment-naïve patient populations, especially in hematologic malignancies and solid tumors

Cytoart helps you navigate, localize, and operationalize in this ecosystem.

 Our Focus: Cell & Gene Therapy IITs Only

We don’t do everything — we only do CGT. Our team has supported:

  • Autologous CAR-T / TCR-T trials (e.g., BCMA, CD19, Ropporin-1)

  • Allogeneic and off-the-shelf NK / γδ-T platforms

  • Gene-modified stem cell therapies and viral/mRNA vector studies

What We Offer

Full-Service IIT Enablement in China

  • Protocol writing (bilingual: English & Chinese)

  • Regulatory advisory and IRB submission

  • Site and PI engagement

  • Project management & GCP compliance

  • Real-time CAR expression and sample testing

  • Safety oversight and AE/SAE handling

  • Data management, stats, and CSR preparation

Value-Driven, Flexible Models

  • Cost-effective packages designed for early-stage biotech and academic collaborations

  • Milestone-based pricing and modular services

  • Options for Cytoart-led clinical execution or co-managed models with your team

Beyond Clinical: Infrastructure Support

Through our trusted CDMO and technology partners, Cytoart offers a seamless extension from trial planning to execution readiness:

  • GMP Consulting & Facility Readiness
    Guidance on site setup, environmental monitoring, and tech transfer planning — tailored for hospital-based or decentralized manufacturing models

  • SOP Development & Localization
    Clinical and manufacturing SOPs adapted to Chinese regulatory and operational standards

  • Vector Sourcing & Technology Transfer
    Coordination with local and international CDMO partners for lentiviral vector supply, plasmid support, and process transfer

  • Training for Clinical & Production Teams
    On-site or virtual training programs for investigators, QA/QC teams, and manufacturing technicians — ensuring compliance and consistency

  Why Cytoart?

  • We speak biotech — deep understanding of early-phase CGT development

  • We speak China — trusted by >20 Chinese CGT leaders for RUO, IIT, and clinical support

  • We speak both — bridging international partners with Chinese clinical innovation

Let’s Launch Your China IIT

Whether you’re validating a novel construct, generating real-world data, or exploring a new indication — IITs in China can accelerate your path.

Contact Cytoart today to explore a project or request a custom IIT proposal.