Are CAR-Ts Safe? Investigating the Magnitude of the Risks
Wednesday, May 29, 2024 01:00 PM - 02:00 PM
Room 212-214
Regulation & Policy
Roundtable
Organized by: ISCT
Moderator
Moderator
- Bruce Levine, PhD, University of Pennsylvania, United States
- Anna Sureda, MD, PhD, Institut Catala d'Oncologia, Spain
- Robert Sokolic, MD, Malignant Hematology Branch, FDA, United States
- Rahul Banerjee, MD, FACP, University of Washington, United States
- Elise A. Chong, MD, University of Pennsylvania, United States
Key Learning Objectives:
1. The US FDA has announced an investigation into reported cases of secondary T cell malignancies amongst other secondary malignancies following CAR T cell therapies. What is known and unknown surrounding these cases?
2. What actions should be expected of manufacturers, treating physicians, and patients?
3. How should the relative benefits and risks be discussed with patients and the public?
4. What does the reporting on these issues tell us about the development of advanced cell and gene therapies?
1. The US FDA has announced an investigation into reported cases of secondary T cell malignancies amongst other secondary malignancies following CAR T cell therapies. What is known and unknown surrounding these cases?
2. What actions should be expected of manufacturers, treating physicians, and patients?
3. How should the relative benefits and risks be discussed with patients and the public?
4. What does the reporting on these issues tell us about the development of advanced cell and gene therapies?
Bruce Levine
Barbara and Edward Netter Professor in Cancer Gene Therapy
University of Pennsylvania
Moderator
Barbara and Edward Netter Professor in Cancer Gene Therapy
University of Pennsylvania
Moderator
Anna Sureda
Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme
Institut Catala Oncologia
Panelist
Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme
Institut Catala Oncologia
Panelist