Clinical Trial Studies

DartLab offers a range of services to facilitate Phase I and II clinical trials, including panel development, cell staining, cell sorting, flow cytometry, and data analysis. To arrange services for a clinical trial, please contact Dr. Smith to consult on research needs and experimental design.


Previous Clinical Trials

Title Phase PI Category

*by DartLab

Treatment of multiple sclerosis with anti-CD154: a phase II double-blind partial cross-over clinical trial (IDEC/ITN). Mechanistic Kasper monitoring*
A trial of a CD40 activated dendritic cell vaccine in patients with resected colorectal cancer (NCI). Phase II Barth vaccine/monitoring*
The effect of CNTO 1275 on the immune responses of peripheral blood cells from subjects with relapsing forms of multiple sclerosis (Centocor). Mechanistic Kasper monitoring*
Dose-escalation study of EMD 273066 administered with low-dose cyclophosphamide to subjects with epithelial cell adhesion molecule (EpCAM) positive advanced cancers. Phase I Ernstoff cellular
Dose dependent induction of T regulatory cells by glatiramer acetate: a parallel mechanistic study to GA9016 (TEVA Pharmaceuticals) Mechanistic Kasper monitoring*
Longitudinal study of mild cognitive Iimpairment and early Alzheimer’s disease. Monitor Saykin cytokine*
Autologous PBSC and immunotherapy for myeloma. Phase III Meehan cellular/cytokine
Immune mobilization of autologous PBSC with IL-2 and GM-CSF Phase III Meehan cytokine
Immunologic evaluation of peripheral blood. Monitor Ernstoff monitoring
Autologous tumor/DC vaccine + IL-2 & IFNα in renal  cell cancer. Phase II Ernstoff vaccine/cytokine
Pre-clinical studies for development of a DC in GBM Pilot Fadul vaccine
IL-2 in lymphodepleted primed melanoma patients. Phase II Ernstoff cytokine
Adjuvant intra-nodal autologous DC in GBM. Phase II Fadul vaccine
Cryoablation as immunomodulator in breast cancer (Sanarus). Pilot Barth vaccine/monitoring*
VEGF blockade autologous DC, IL-2, and IFNa-2b in renal cell cancer. Phase II Ernstoff vaccine/cytokine
Cellular immunoRx, after autologous PBST for myeloma. Phase II Meehan cellular
Modulation of immune system by VEGF in GBM. Pilot Fadul antibody
Melanoma and renal tumor tissue bank extension. Monitor Ernstoff monitoring
Immune endpoints in blood & BM myeloma and healthy subjects. Monitor Meehan monitoring
Immunological effects of GM-CSF/vaccine in renal cell cancer and melanoma. Pilot Ernstoff vaccine/cytokine
Leukapheresis for immunological endpoints. Monitor Ernstoff monitoring
GM-CSF in patients with prostate cancer. Pilot Ernstoff cytokine
Bevacizumab + IL-2 in renal cell cancer. Phase II Ernstoff cytokine/antibody
Melacine plus IFNa-2b vs. IFNa-2b in melanoma. Phase III Ernstoff vaccine/cytokine
Induction of T regulatory cells in relapsing-remitting multiple sclerosis following treatment with anti-CD52 (Campath 1-H; Genzyme) Mechanistic Kasper cellular/                    cytokine/monitoring*
Induction of T regulatory cells and the effect on B cells by IFNb-1b (Bayer) Mechanistic Kasper monitoring*
The relationship between thymic activity, regulatory T-cells and functional immune status in organ transplantation with alemtuzumab (Campath-1H) pretreatment and tacrolimus monotherapy. Pilot Zuckerman cellular/monitoring*
The effect of psychosocial and behaviorally-based interventions on biological outcomes of patients with an advanced cancer diagnosis (NIH). Pilot Bakitas cellular/                   cytokine/monitoring*
Evaluation of the effect of age and prior immunity on the response to live or inactivated seasonal influenza vaccines in children (NIH). Pilot Wright cellular/cytokine/monitoring*
An open-label, dose-escalation, phase I study of the safety, tolerability and immunogenicity of the prime-boost regimen of the investigational 2012/13 seasonal influenza DNA vaccine followed by the 2012/2013 seasonal influenza trivalent inactivated vaccine (TIV) compared to TIV prime-TIV boost in children and adolescents ages 6-17 Years (NIH). Phase I Wright cellular/cytokine/monitoring*
Immune monitoring of the effects of an RXR nuclear receptor agonist on peripheral blood mononuclear cells from patients with Parkinson’s disease (Io Therapeutics, Inc.). Phase I Channon cellular/cytokine/monitoring*
Pilot studies to determine the effects of an RXR nuclear receptor agonist on peripheral blood mononuclear cells from healthy individuals (Io Therapeutics, Inc.). Pilot Channon cellular/cytokine
Pilot study to evaluate the efficacy and safety of plasma exchange with human albumin in patients with amyotrophic lateral sclerosis (Grifols Biologicals Inc.). Phase I Channon cellular/cytokine/monitoring*
A Phase I Study of De-immunized DI-Leu16-IL2 Immunocytokine administered subcutaneously in Patients with B-cell Non-Hodgkin Lymphoma (Alopexx Pharmaceuticals LLC). Phase I Channon cellular/cytokine/monitoring*