Phase I/IIa Study of RNActive®-Derived Therapeutic Vaccine in Advanced or Metastatic Hormone Refractory Prostate Cancer
At present, no curative therapy is available for subjects with advanced or metastatic
prostate cancer. Approximately 1 of every 3 men present with advanced or metastatic
disease; therefore, current standard therapies are ineffective and new therapeutic
approaches are warranted. There is ample evidence that active immunotherapy against cancer
is safe and capable of stimulating potentially therapeutic immune responses in the cancer
patient. Moreover, several Phase II immunotherapy trials have suggested clinical benefit by
reducing the tumor mass or prolonging time to progression in subjects with advanced prostate
CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on
CureVac's RNActive® technology. CV9103 encodes for 4 prostate specific antigens. Because
these antigens are present in prostate cancer cells, they are appropriate targets for
intervention. These antigens have been shown to correlate frequently with the progression of
prostate cancer, and are known to be immunogenic in humans, where they induce antigen
specific T-cell or B cell expansion.
As an RNA-based vaccine, CV9103 features several advantages over other approaches: it is
highly specific, there is no restriction to the patient's MHC genotype, and it does not need
to cross the nuclear membrane to be active. Finally, in the absence of reverse
transcriptase, RNA can not be integrated into the genome.
CV9103 will be administered in 5 doses.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Assessment of Safety and Tolerability of the Trial Regimen
Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0: All Categories equal or greater than grade 3 Allergy/autoimmunity equal or greater than grade 2 Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.
At Nine Weeks with Follow Up at One Year
Johannes Vieweg, MD FACS
Univeristy of Florida, College of Medicine
United States: Food and Drug Administration
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