Toxicity Reporting in CART Miguel Angel Perales MD

Miguel Perales MD Disclosures: • Member, Scientific Advisory Board: – Mol. Med, Nex. Immune

Important Issues to Address in Establishing Mechanism for Long-term Follow-up of Cellular Therapy All

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

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

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

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

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

• Design similar to Gv. HD notes with Clinical and Consensus options •

Slides: 21

Download presentation

Toxicity Reporting in CAR-T Miguel Angel Perales MD Adult Bone Marrow Transplantation Service Memorial Sloan Kettering Cancer Center 2019 TCT Meeting Houston – February 21 2019

Miguel Perales MD Disclosures: • Member, Scientific Advisory Board: – Mol. Med, Nex. Immune • 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

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

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

What Data should we collect? VS.

What Data should we collect?

Lee, Santomasso et al, BBMT 2018

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

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

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

The ASBMT Mobile App

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

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