Protara Therapeutics has dosed the first subject in the Phase I ADVANCED-1 clinical trial of an investigational cell therapy, TARA-002, to treat non-muscle invasive bladder cancer (NMIBC).
The innate and adaptive immune cells within the cyst or tumour are believed to trigger and elicit a robust immune cascade on administering the investigational cell therapy.
The open-label, dose-finding trial will assess the cell-based immunopotentiator TARA-002 in NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumours (Ta), who are treatment-naïve and those who received treatment previously.
Subjects in the preliminary dose-escalation portion of the trial will be given six intravesical doses of the therapy per week.
Analysing the cell therapy’s safety, tolerability and initial anti-tumour activity signs to detect a recommended dose for a planned Phase II trial will be the Phase I trial’s primary objective.
Protara Therapeutics CEO Jesse Shefferman said: “NMIBC is one of the most recurrent and difficult to treat cancers with very limited treatment options.
“We are thrilled to have dosed the first patient in our Phase I study in NMIBC and look forward to exploring TARA-002’s full potential in this pressing area of high unmet need.”
TARA-002 is derived from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator currently marketed in Japan and Taiwan.
In October last year, the US Food and Drug Administration (FDA) granted clearance to the Investigational New Drug application submitted by the company for TARA-002 to treat NMIBC.
It has also received Rare Pediatric Disease Designation from the FDA.
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