Fate Therapeutics, Inc./FT819-102/Elsedawy/07-15-2026/Continuing Review 1 of 3

MEETING MINUTES

Meeting Date: Wednesday, July 15, 2026

Time: 11:00 am Central Time

Location: Zoom Teleconference

Institution: Regional One Health, Memphis, TN

Principal Investigator: Noura Elsedawy, MD

Protocol: Fate Therapeutics, Inc., FT819-102

NCT Number: NCT06308978

Meeting Type: Continuing Review of Protocol and Site

Title: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic

Lupus Erythematosus

  1. Call to order:

The Meeting was called to order at 11:00 am Central Time.

  1. Introductions and orientation:

Introductions were made and the Chair oriented members to the meeting procedures.

  1. Declaration of quorum:

Four voting members were present, including one local member unaffiliated with the institution. Also present were

four Institutional Representatives and IBC Services staff. The Chair declared that a quorum was present.

  1. Conflict of Interest:

The Chair requested that voting members report any conflict of interest regarding this meeting. No conflicts of

interest were reported.

  1. Public posting:

An Institutional Representative confirmed that notice of the meeting was not publicly posted since site staff were not

available on site to do so.

  1. Approval of previous meeting minutes:

Minutes Approved – YES: 4 NO: 0 ABSTAIN: 0

  1. Review of proposed research:

The Chair provided an overview of the protocol and status of the study.

The Chair noted changes since the last review.

  1. Determination for biosafety level and period of IBC oversight:

The Committee previously determined that BSL-2 containment facilities and practices are required for FT819

since it consists of primary human cells modified by recombinant plasmids and a

. The Committee reaffirmed this determination.

The Committee previously determined that IBC oversight will continue for 3 months after the last subject’s, last

dose of FT819 locally, provided that other biosafety criteria for study closure are also met. The Committee

reaffirmed this determination.

  1. Vote on the Protocol:

The Committee voted for the following determination on the Protocol:

X APPROVED

CONDITIONALLY APPROVED

TABLED

DISAPPROVED

DETERMINATION VOTE – YES: 4 NO: 0 ABSTAIN: 0

INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW

Fate Therapeutics, Inc./FT819-102/Elsedawy/07-15-2026/Continuing Review 2 of 3

  1. Review of proposed facilities and practices:

The Chair provided an overview of the arrangement for the facilities and practices.

Points of Discussion:

  1. An Institutional Representative stated that the study agent arrives onsite in a sponsor-provided cryoport,

which is labelled with a biohazard symbol, and that the study agent remains in the cryoport until the subject

is ready to be dosed. The Committee recommended that a photo of the cryoport, showing the biohazard

symbol, be provided to IBC Services.

  1. An Institutional Representative stated that the blue biohazardous waste containers, as shown in site photos,

are not used for this protocol and that red biohazardous waste containers are brought into the preparation

and dosing rooms at the time of study agent handling. The Committee recommended that photos of the red

biohazardous waste containers in these rooms be provided to IBC Services.

  1. An Institutional Representative stated that the red biohazardous waste containers in the subject bathrooms

(within the dosing rooms) are not used for biohazardous waste disposal for this protocol.

  1. An Institutional Representative stated that disposable eyewash bottles are available in the dosing rooms.

The Committee recommended that site documents be revised accordingly to reflect this.

  1. Site requirements:

The Chair reviewed training and communication requirements for maintaining IBC approval with the Institutional

Representatives.

  1. Vote on the Site:

The Committee voted for the following determination on the Site:

X APPROVED

CONDITIONALLY APPROVED

TABLED

DISAPPROVED

DETERMINATION VOTE – YES: 4 NO: 0 ABSTAIN: 0

  1. Advice to the Institution: None.
  2. Meeting adjourned: The meeting was adjourned at 11:10 am Central Time.
  3. Post-meeting notes: None.

Documents reviewed:

Agenda

Protocol, Version 7.0, dated 04-02-2026

Protocol Administrative Letter, dated 12-17-2025

Investigator’s Brochure, Version 12.0, dated 02-05-2026

Pharmacy Manual, Version 3.0, dated 02-23-2026

Research Modification Evaluation, Protocol, Version 6.0

Research Modification Evaluation, Protocol, Version 7

Research Modification Evaluation, Protocol Administrative Letter, dated 12-17-2025

Research Modification Evaluation, Investigator’s Brochure, Version 10.0

Research Modification Evaluation, Investigator’s Brochure, Version 11.0

Research Modification Evaluation, Investigator’s Brochure, Version 12.0

Research Modification Evaluation, Pharmacy Manual, Version 3.0

Biological Risk Assessment and Summary, updated 04-17-2026

Research Modification Evaluation Form, Principal Investigator Change, dated 03-12-2026

Site Maps, dated 07-24-2025

Site Inspection Checklist, dated 07-28-2025, updated 03-03-2026

Photos, dated 07-22-2025

Biohazard Sign, FT819, dated 03-12-2026

SOP, Biosafety for FT819, dated 07-01-2026

Training, Shipping Certification, expires 09-25-2026

CRRF, dated 04-01-2026

CV, Elsedawy, N., signed 07-25-2025

INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW

Fate Therapeutics, Inc./FT819-102/Elsedawy/07-15-2026/Continuing Review 3 of 3

Prior Meeting Minutes, Initial, dated 07-29-2025