Notification
In line with the NIH Guidelines, all IBC (Institutional Biosafety Committee) meetings on, or after June 1, 2025, the approved minutes must be post publicly on an institutional website.
See below for the agenda/ minutes for IBC meetings.
Any questions or concerns can be directed to our clinical trial team (302-366-1200).
IBC Meeting Minutes- July 1, 2025
Meeting Date: | July 1, 2025 at 10:00AM Eastern Time | ||||||
Meeting Place: | Teleconference (Remote) Meeting is open to the public | ||||||
Members in Attendance: |
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Members Not in Attendance: |
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Guests: | None | ||||||
Staff: | Hemmelgarn, Marian | ||||||
Institution: | Medical Oncology Hematology Consultants, PA |
Call to Order: The meeting was called to order at 9:59 AM. A quorum was present.
Conflicts of Interest: None declared by voting members of the IBC.
Meeting Minutes: Previous meeting minutes were reviewed and approved with no requested changes.
New Business:
PI: | Misleh, Jamal MD |
Sponsor: | Allogene Therapeutics, Inc. |
Protocol: | ALLO-501A-202 |
A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-Cell Lymphoma | |
Review Type: | Annual Review |
NIH Guidelines: | III-C |
Trial Summary: ALLO-501A-202 (ALPHA3 Study) is a Phase II randomized, open-label study sponsored by Allogene Therapeutics, Inc. designed to assess the safety and efficacy of cemacabtagene ansegedleucel (cema-cel; formerly known as ALLO-501A) for the treatment of large B-cell lymphoma (LBCL) in adult subjects with minimal residual disease (MRD) after completion of first line (1L) therapy. Cema-cel is a genetically engineered allogeneic chimeric antigen receptor (CAR)-T cell product that targets CD19, a tumor antigen highly expressed on the surface of certain B cell malignancies.
Biosafety Containment Level per Risk Assessment: BSL-2
Comments:
- The Committee reviewed the Sponsor’s study documents and the comprehensive study-specific Risk Assessment which provided a thorough description of the recombinant or synthetic nucleic acid molecules (“investigational product [IP]”) and the proposed clinical research involving the IP.
- The Committee agreed that the potential risks and occupational exposure hazards associated with handling the IP in this clinical trial were well-described in the Risk Assessment.
- The Committee reviewed the Site’s facility details, study-specific procedures and practices, training records, Annual Review Report and other applicable information provided by the Site for the purposes of the IBC review.
- The Site verified that the information provided by the Chair was accurate.
- The Site confirmed the accuracy of the Annual Review Report.
- The Committee discussed the non-sharps biohazard waste container in the Pharmacy. The Site indicated the open yellow biohazard waste container seen in the Pharmacy Prep and Storage Area is used for non-sharps waste. The Committee reminded the Site that sharps and non-sharps waste should be kept segregated and recommended the Site provide an updated photo of the non-sharps biohazard waste container.
- The Committee discussed the cardboard biohazard waste container in the Biohazard Waste Storage Area and recommended the Site place a plastic tray under the cardboard container to mitigate any potential spills.
- The Committee discussed Biohazardous waste in the administration room. The Site clarified that non-sharps biohazard waste is removed from the administration rooms after agent administration.
Motion: A motion of Full Approval for the study at BSL-2 was passed by majority vote. There were no abstentions on voting.
- Contingencies stated by the Committee: None
- Stipulations stated by the Committee: None
Reminder of IBC Approval Requirements.
Adjournment: 10:26 AM
Post-Meeting Pre-Approval Note: None
