Search results for "Phase i ii"
showing 5 items of 5 documents
A first-in-human phase I/II clinical trial assessing novel mRNA-lipoplex nanoparticles encoding shared tumor antigens for potent melanoma immunothera…
2017
A Phase I/II Dose-Escalation Multi-Center Study to Evaluate the Safety of Infusion of Natural Killer Cells or Memory T Cells As Adoptive Therapy in C…
2021
Abstract Background: Adoptive cell immunotherapies for opportunistic virus in immunocompromised patients using haploidentical memory T cells have shown to be safe and effective. Since severe cases of COVID-19 present a dysregulated immune system with T cell lymphopenia and a hyper-inflammatory state we have proposed that a similar strategy could be proven to be efficient for COVID-19 patients. This is a study protocol of an open-label, multicenter, double-arm, randomized, dose-finding phase I/II clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of the administration of a single dose of allogenic SARS-CoV-2 specific memory CD45RA - T cells and Natural Killer (NK)…
Results of a Phase I-II Pilot Study with Intravescical Gemcitabine in Superficial Bladder Cancer (Ta-T1)
2005
To study the ablative activity of intravescical gemcitabine against superficial transitional cell carcinoma of the bladder at different doses and concentrations. Methods Twenty-seven patients were treated with intravescical gemcitabine after transurethral resection, during which one to three papillary marker lesions were left unresected. Starting 14 days after transurethral resection, six gemcitabine instillations were given at weekly intervals. Gemcitabine, diluted in 50 mL of saline solution and maintained for 2 hr, was given at a dose of 500, 1000 and 2000 mg in groups of nine patients each. A complete response (CR) was defined as negative cutologycystoscopy and biopsy findings. Results…