Table 2.
Clinical trials with autologous DC/DCeu generated from leukemic PBMNC
| Patients included in the study, n | Stage of disease | Source of DC | Cytokines used for DC generation | Vaccination protocol | Immunological effects | Clinical effects | Ref. |
|---|---|---|---|---|---|---|---|
| 5 | AD | Autologous DC/DCleu | GM-CSF | s.c. | ↑ PRAME (LAA)-specific CD8+ T cells | CR 3/5 | 89 |
| IL-4 | Four vaccinations | ↑ TH-1 cytokine release | PD 2/5 | ||||
| TNF-α | biweekly | ↑ IFN-γ CD4+ cells | No major side effects | ||||
| 5 × 106 DC/DCleu | |||||||
| 5 | After achieving CR | Autologous DC/DCleu | GM-CSF | s.c. | ↑ IFN-γ secreting antileukemic CTL | No evidence of a clinical benefit | 90 |
| IL-4 | 4 vaccinations | ↑ WT1-specfic CTL | (no control group) | ||||
| TNF-α | weekly | no change in amounts of Treg | Induction of autoimmunity (1/5) | ||||
| INF-γ | escalating doses: | ||||||
| poly I:C | 0.125 × 106 to 1 × 106 DC/DCleu | ||||||
| 21 | AD | Autologous DC/DCleu | GM-CSF | i.v. | ↑ CD3+, CD4+CD3+, CD8+CD3+ compared | CRa 6/21 | 88 |
| + | INF-α | 5 vaccinations | to before culture | PRa 9/21 | |||
| autologous CIK cells | FLT3 L | 7.36±0.48 ×107 DC/DCleu | f IL 12, IL 2, IL 7, INF-γ, and TNF-α | NR 6/21 | |||
| + | SCF | compared to before culture | Mild side effects | ||||
| low dose CTX | TGF-β | ||||||
AD, advanced disease; CR, complete remission; CIK cells, cytokine-induced killer cells (CD3+CD56+ cells); CTX, chemotherapy; s.c., subcutaneous; i.v., intravenous; CR, complete remission; PD, persisting disease; PR, partial remission; ↑, increase; CTL, cytotoxic T lymphocyte; Treg, regulatory T cells.
a
Significantly higher compared to the control group