Table 3.

IFN-γ responses to recipient-derived PHA blasts and skin fibroblasts before and after immunizations (ELISPOT)



IFN-γ spots/106 PBMCs
Pt/dosage and target*
Before study
After 3 injections
After 6 injections
2/1    
   PHA blasts   13   9   20  
   SKF   0   0   18  
3/1    
   PHA blasts   200   505   527  
   SKF   0   0   0  
4/1    
   PHA blasts   493  297   59  
   SKF   383  118   20  
6/2    
   PHA blasts   NA   NA   NA  
   SKF   18   67   32  
7/2    
   PHA blasts   10   485   370  
   SKF   0   60   90  
8/3    
   PHA blasts   0   NA   10  
   SKF
 
0
 
NA
 
146
 


IFN-γ spots/106 PBMCs
Pt/dosage and target*
Before study
After 3 injections
After 6 injections
2/1    
   PHA blasts   13   9   20  
   SKF   0   0   18  
3/1    
   PHA blasts   200   505   527  
   SKF   0   0   0  
4/1    
   PHA blasts   493  297   59  
   SKF   383  118   20  
6/2    
   PHA blasts   NA   NA   NA  
   SKF   18   67   32  
7/2    
   PHA blasts   10   485   370  
   SKF   0   60   90  
8/3    
   PHA blasts   0   NA   10  
   SKF
 
0
 
NA
 
146
 

Patient 1 (dose level 1) experienced early disease progression. Patients 5 (dose level 2), 9 (dose level 3), and 10 (dose level 3) did not have enough blasts remaining for immunologic studies.

PBMCs indicates peripheral blood mononuclear cells; SKF, skin fibroblasts; and NA, not available.

Differences in IFN-γ secretion before and after immunization were not statistically significant whether patient-derived skin fibroblasts (P > .5) or PHA blasts (P > .345) were used as targets.

*

The dose-escalation schedule began at 2 × 105 CD40L-secreting skin fibroblasts per injection (dose level 1), increasing in log increments to 2 × 107 (dose level 3). IL-2-secreting skin fibroblasts and recipient-derived blasts were administered at a fixed dosage throughout the study (2 × 107 per injection)

No PBMCs available prior to 1 week after the first immunization for patient 4

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