1. Toxicity Reporting in CAR-T
Miguel Angel Perales MD
Adult Bone Marrow Transplantation Service
Memorial Sloan Kettering Cancer Center
2019 TCT Meeting Houston – February

2. Miguel Perales MD Disclosures:
Member, Scientific Advisory Board:
MolMed, NexImmune
Ad hoc Advisory Board:
Abbvie, Bellicum, Incyte, Nektar Therapeutics, Novartis
Member, DSMB:
Medigene, Servier
Consulting:
Merck
Research Funding:
Incyte (clinical trial), Miltenyi (clinical trial)
Academic/Not-for-Profit:
Board Member: ASBMT, Be The Match (NMDP)
CIBMTR Advisory Committee
Tufts Cancer Center DSMB, University of Barcelona CAR T trial DSMB

5. Important Issues to Address in Establishing Mechanism for Long-term Follow-up of Cellular Therapy
All Patients
All Data
Quality
Long-term
Follow-up
Confidential
Secure
Compliant
Available
Cost
Effective

6. What Data should we collect?
Who do we
report to?
How do we report Data?

7. What Data should we collect?
VS.

8. What Data should we collect?

9. Lee, Santomasso et al, BBMT 2018

10. ASBMT Cytokine Release Syndrome (CRS) Consensus Grading for Adults
Lee, Santomasso et al, BBMT 2018

11. ASBMT Neurotoxicity (NT) – ICE Score Consensus Grading for Adults
Lee, Santomasso et al, BBMT 2018

12. ASBMT Neurotoxicity (NT) – ICE Score Consensus Grading for Adults
Lee, Santomasso et al, BBMT 2018

13. ASBMT Neurotoxicity (NT) – ICANS Grade Consensus Grading for Adults
Lee, Santomasso et al, BBMT 2018

14. The ASBMT Mobile App

15. The ASBMT Mobile App

16. IEC Toxicity and Status Assessment – MSK Experience
How do we report Data?
IEC Toxicity and Status Assessment – MSK Experience

18. Design similar to GvHD notes with Clinical and Consensus options
Mandated Weekly Clinical Assessments to day 28
Option for Event-Driven Assessment (i.e. CRS or Neurotox)