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Clinical Trial Contributions

Page history last edited by Per.Marits@ki.se 1 day, 13 hours ago

Clinical Trials with Immunotherapuetic Agents - Publish dates no older than 6 months

 

Contribution Instructions

You can add a new trial or comment on previous listings. For comments, please indicate what you think about the trial. Is it important enough to include? Is it of interest outside the subspecialty area? Are there key points missing in the summary table? Is it accurate? To edit the page please follow the steps below.

1. Select the Edit tab at the top of the page.

2. Enter the trial information under the approprate column headers. The first entry is a sample.

3. Comment on previous posts using the Comment box at the bottom of the page and referencing the trial number in the first column.

4. When finished, click Save at the bottom of the page and log out in the upper right corner.

5. Contact FOCIS Program Manager, Sarah Krause at (414) 359-1670 x103 or smartis@focisnet.org with any questions.

 

#  Citation  Disease  Study Design Drug Safety/ Efficacy Additional information of interest
to FOCIS Community  
Submitted by: 
1 SAMPLE: Hueber et al. Sci Transl Med. Oct 6, 2;52: 52ra72, 2010 [PMID: 20926833]. Psoriasis, RA, non-infectious uveitis  Double-blind, randomized (uveitis - open lable, non-randomized). A total of 60 patients received active treatment; 44 placebo.  AIN457; a monoclonal anti-IL17A antibody (IgG1) 

No major adverse events. 

Evidence of clinical benefit in all three diseases. 

This is a small preliminary study with short follow-up. Therefore, conclusions regarding efficacy should be drawn with some caution. Similarly, long-term side-effects cannot be evaluated. However, the strategy seems to hit a biologically relevant target, as indicated by the reduced expression of multiple inflammatory mediators in psoriatic skin biopsies upon active treatment. Dosing schedules needs to be optimized before proceeding to larger trials.

Per Marits, Karolinska Institute, Stockholm, Sweden

 

 

 

 

 

 

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Liu et al. Clin Cancer Res. Mar 15, 18;6: 1751, 2012 

Metastatic Renal Cell Carcinoma 

Phase II clinical trial: 148 patients were randomized to either two CIK cell infusions/month or s.c. IFN-g + IFN-alpha-2a /every 6 weeks.

Short-term cytokine-expanded autologous PBMC

No major adverse events with cell therapy. CIK cell transfer provided significantly longer progression-free and overall survival.

The results in this randomized trial contrasts to those obtained with LAK and TIL cells in RCC. Cytokine-Induced-Killer (CIK) cells are described as CD3+CD56+, but 80% of the transferred cells were phenotypically T-lymphocytes. The expanded cells displayed cytotoxicity against allogenic RCC cell lines, but their exact mechanism of action remains unclear. Nevertheless, the data are promising and the authors plan to proceed to multicenter phase III trials of this treatment modality. 

Per Marits, Karolinska Institute, Stockholm, Sweden 

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