Adoptive Immunotherapy With Autologous CD3/CD28-Costimulated T-Cells After Fludarabine-Based Chemotherapy In Patients With Chronic Lymphocytic Leukemia
Stephen J. Schuster, Chitra M. Hosing, Elizabeth J Shpall et al.
Key Points:
Multicenter phase I/II trial for adoptive immunotherapy using autologous CD3/CD28-costimulated T-cells expanded ex vivo (ACTC), enhances immune reconstitution after fludarabine-based therapy or alemtuzumab-based therapy of lymphoma.
- Primary study endpoints - ability to generate a T-cell dose of 1.0 E+10+/- 20% with safety, which is less than grade 3 non-hematologic toxicity; secondary endpoints - evaluate immune reconstitution
- Median fold CD4 increase 2.3 and median fold CD8 increase 1.1
- PFS for untreated patients - 42 months; 12 months for relapsed patients.
Implications:
- ACTC infusion results in dose-independent acceleration of CD4+ and CD8+ cells.
View the original abstract on the ASH website.
