CARE GVHD Trial Timeline

sequential infusions of regulatory-T-cell-enriched allodepleted leukocytes for the treatment of steroid- refractory or dependent chronic GVHD: A multicenter controlled phase II clinical trial

Events

Health Canada

Complete Pre-IND Package

09/25/2014 - 11/01/2014

Submit documents for Pre-IND meeting with Health Canada

11/03/2014

Study Development

Development of Lab Procedure Manual

09/25/2014 - 12/15/2014

Development Investigator Brochure

09/25/2014 - 12/15/2014

Finalized Lab Procedure Manual and Batch record

12/15/2014

Finalized Investigator Brochure

12/15/2014

Clinical Trial Operations

Obtain comments from Clinical Trial Review Committee

09/25/2014 - 11/01/2014

Respond to CNTRP Clinical Trial Review Comments

11/03/2014 - 12/15/2014

Study Sites

2-3 Dry runs completed at HMR

11/01/2014 - 12/15/2014

Determine shipping for sites not processing cells

11/01/2014 - 12/15/2014