Laboratory and clinical biomarkers for adverse event monitoring
| Adverse event monitoring biomarker . | SCT or GT/E . | Direct or surrogate biomarker . | Biomarker value validation . |
|---|---|---|---|
| Laboratory biomarkers | |||
| Vector integration sites | GT/E | Surrogate | Strong |
| Transgene variegation and silencing | GT/E | Surrogate | Strong |
| Off-target mutagenesis | GT/E | Possibly predictive | Strong |
| Clinical biomarkers | |||
| Early vs late graft rejection | SCT | Direct | Intermediate |
| Alloantibody development | SCT | Direct | Intermediate |
| Acute vs chronic GVHD biomarker panels | SCT | Surrogate | Research gap |
| Adverse event monitoring biomarker . | SCT or GT/E . | Direct or surrogate biomarker . | Biomarker value validation . |
|---|---|---|---|
| Laboratory biomarkers | |||
| Vector integration sites | GT/E | Surrogate | Strong |
| Transgene variegation and silencing | GT/E | Surrogate | Strong |
| Off-target mutagenesis | GT/E | Possibly predictive | Strong |
| Clinical biomarkers | |||
| Early vs late graft rejection | SCT | Direct | Intermediate |
| Alloantibody development | SCT | Direct | Intermediate |
| Acute vs chronic GVHD biomarker panels | SCT | Surrogate | Research gap |