Your CMC section will not be the same - changing from autolgous cells to master bank cells is a major change in your CMC.
Depending on the data available on the safety and performance of the master bank cell with your modification you might or might not be able to move directly to phase II.
You might consider consultation with the FDA, or submitting a new IND to force a 30 days clock to obtain concurrence or hold comments from the FDA.
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Shy Shorer MD, MBA, EJD
Director, Office of Sponsor and Regulatory Oversight
Center for Cancer Research
National Cancer Institute
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Original Message:
Sent: 04-Mar-2020 22:51
From: Anonymous Member
Subject: Autologous cell therapy product switch to Allogeneic cell therapy product
This message was posted by a user wishing to remain anonymous
Hi all,
We have an active IND in phase 1 stage for an autolgous cell therapy product (cells from patient, after correction, delivered back to the same patient). We plan to move to allogeneic (generate a master cell bank which can be used to deliver in any patient) product in phase 2. The CMC will the same, the patient population and indication also will be the same. Only source of the cells will be changed from autologous to allogeneic. Please suggest a regulatory strategy which we should use for this change.
Thanks!