Research Institute
Institutional Biosafety Committee (IBC) Meeting
Tuesday, June 3, 2025; 4:30 – 5:15 PM
MINUTES
| IBC Members Present | Designation |
|---|---|
| Cathy Y. | Community Member |
| Pierre Desprez, Ph.D. (Chair) | CPMC Research Senior Scientist |
| Robyn J. | CPMC Research Technician |
| Yihui S., M.D., Ph.D. | CPMC Research Senior Scientist |
| Angeline M. | IBC Administrator |
| Chris C. | Facilities Lab Manager |
IBC Quorum: A quorum of 6 was attained. Notes and comments from Dr. Ruiz were provided to Dr. Pierre Desprez ahead of the meeting.
Location: via Zoom
The meeting was called to order at 4:30 pm. This was an open meeting.
Welcome and Updates (Angeline Monton)
IBC personnel changes are occurring. Martin Wu has retired from CPMCRI and has departed from the IBC. We welcomed Chris C. and Cathy Y. to the IBC. Chris C. has taken over as the facilities lab manager at the Brannan lab, and Cathy Y. has joined as a community member. Inquiries will be made to create additions to the IBC.
An updated roster, dated May 2025, was provided.
Angeline provided an update on the number of IBC studies open at CPMCRI. Currently there are 7 studies open. Dr. Desprez pointed out that much of the work of the IBC as of recently has been mainly administrative, which he and Angeline have been handling, so that is why the IBC has not been called to a meeting until now.
Dr. Desprez provided updates from the NIH for registered IBCs. As of June 1st, rosters and the contact information for IBC chair and IBC contact were made publicly available through the IBC-Registration Management System. Also, for meetings taking on or after June 1st, approved minutes from those meetings must be publicly posted on the institution’s website. Dr. Desprez and Angeline will be working to ensure this occurs.
Discussion and Protocol Review (Pierre Desprez, Ph.D.)
Protocol Review for 2025.001 (KRI) Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Dr. Desprez provided a brief overview of the study, which is to be carried out at the Sutter Health Alta Bates campus and confirmed that the study overview on the registration form was understood by all IBC 2 Members. The goal of this project is to stimulate the immune system in patients with relapsed or refractory multiple myeloma by injecting ide-cel.
Dr. Desprez has been working with this team to obtain all completed paperwork to be reviewed at this meeting.
These 4 study documents were provided via email prior to meeting date:
- BB2121-EAP-001 --- IBC FORM_REGISTRATION_May14,2025 (part 1) - signed
- BB2121-EAP-001 --- IBC FORM_Appendix A_Nucleic Acids_May14,2025
- IB bb2121_bms986395_v10_25Mar2024
- BB2121-EAP-001_Protocol Amendment 03_07May2024
Dr. Desprez reviewed the latest documents with the IBC, and inquiries were resolved. All study personnel must sign the registration form before IBC approval can be administered, as this signifies that they are confirming that they are knowledgeable any safe handling procedures.
Dr. Ruiz and Dr. Desprez had questioned the word “nonconforming” in the title of the study, but Dr. Desprez was able to pinpoint a definition in the protocol amendment (4. BB2121-EAP-001_Protocol Amendment 03_07May2024). The study overview in the Registration Form must be modified to include a brief explanation of “nonconforming” (copy and paste from the amendment).
Appendix A (2. BB2121-EAP-001 --- IBC FORM_Appendix A_Nucleic Acids_May14,2025), which contained great detail from the study team, was then reviewed. Details about the injected vector were shared as well as safe-handling procedures. It was noted that the vector will not pose as great of a threat to the personnel working with it as they are going to be receiving the syringes of the vector already-made rather than creating them in the lab themselves or handling them in that kind of capacity. Moreover, the lentiviral vector is not replication competent. But all required training must be completed before the study personnel can work with or handle the materials.
A motion was made and seconded to approve this study conditionally.
The conditions to be satisfied are that:
- All study personnel must sign 1. BB2121-EAP-001 --- IBC FORM_REGISTRATION_May14,2025 (part 1) – signed and complete all CITI training before conducting any experiments.
- An explanation of what “nonconforming” is defined as should be transferred from the protocol amendment (4. BB2121-EAP-001_Protocol Amendment 03_07May2024) to the study overview on 1. BB2121-EAP-001 --- IBC FORM_REGISTRATION_May14,2025 (part 1) – signed.
Voting:
Yay = 6
Nay = 0
Abstain = 0
This study is approved conditionally.
Other Business
The next IBC meeting is scheduled for Thursday, June 26, from 12:15-1:15 pm to review another study protocol.
Updates and materials will be provided before the next scheduled meeting.
Meeting end: 5:00 pm