A Phase II Study Testing the Activity and Safety in successfully ART-Treated Subjects Infected with HIV in Combination with ART Followed by ART Interruption. Study Design: The study design is identical to the Phase I study except that after the fourth dose patients will begin a drug treatment interruption period while receiving additional immunizations during that period. This provides an opportunity to assess the impact of the Arcelis therapy on viral load. Current status: Argos has received regulatory approval for this study and is actively accruing patients.

This is a Pilot Study (Phase I/II) testing the immunologic activity and safety of AGS-004, an autologous HIV immunotherapeutic, in HIV-infected adults on HAART. Study Design: Patients that are successfully treated with highly active anti-retroviral therapy (HAART) with no measurable viral load AND have a cryopreserved infectious plasma sample that was drawn immediately prior to initiation of HAART will be administered 4 monthly doses of the Arcelis product.

In ongoing clinical trials (multipeptide loaded cytokine matured moDC +/- CD40L activation in >60 pat.) we have obtained valuable information with high impact on future DC-trials: 1) the presence of 2% DMSO in the thawed final vaccine has no negative impact on the quantity and quality of induced immune responses; thus thawed DMSO containing vials do not have to be centrifuged, but simply diluted; 2) class I peptide loaded cytokine matured DC induce de novo or expand preexisting CD8+ T cell IFN gamma responses in the majority of melanoma patients (>70%), surpri...

We are preparing a protocol for a phase I clinical trial in patients with advanced (stage III or IV) melanoma. Patients will receive a DC vaccination regimen followed by 3 adoptive transfers of autologous in vitro expanded T cells. This novel approach combines in vivo priming by the DC vaccine with passive immunotherapy by lymphocyte infusion. Patients will undergo surgical removal of a metastatic lesion and leukapheresis at the beginning of the trial to provide sources for tumor antigens as well as monocytes and T cells, which will be isolated from the leukaphe...

MAGE-3 positive patients are immunized with autologous MAGE-3 and TK transduced activated T blasts.

HLA-A1 and/or HLA-A2 positive patients are immunized with autologous DC loaded with KLH, as immunological tracer, and an allogeneic peptidome (i.e. natural tumour peptides, NTPs), obtained from melanoma cell line SK-Mel24.

The vaccine is composed by autologous DCs pulsed with apoptotic allogenic prostate carcinoma cell line LNCap.

The vaccine is composed by autologous DCs electroporated with mRNA encoding CD40L, CD70, caTLR4 and one tumorantigen (gp100, Tyrosinase, Mage-C2 or Mage-A3).

We have a current clinical protocol for active immunotherapy in advanced melanoma patients (GMP SOPs covering the protocols are also available). The vaccine is composed by autologous DCs pulsed with allogenic melanoma peptides (SK-Mel 24, HLA-A1 and HLA-A2 positive) plus KLH as immunological tracer and it is produced under GMP condition at MolMed S.p.A. (DIBIT, San Raffaele, Milan, Italy). HLA-A1 and/or HLA-A2 positive patients with stage III/IV melanoma undergo leukapheresis. DCs are generated from adherent peripheral blood monocytes, at day 6 DC are pulsed with ...