View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 25, 2022

Protara initiates dosing in Phase I cell therapy trial for bladder cancer

The trial will analyse safety, tolerability and initial anti-tumour activity signs of TARA-002 in NMIBC patients.

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. 

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper

Secure the cell therapy supply chain from bench to bedside

The development of cell therapies is changing healthcare, delivering new hope to thousands of patients around the world. The vein-to-vein workflow for these therapies, however, is not without challenges, many of which will increase as we scale up to treat more patients. Download this free guide from Cytiva to learn more about the challenges and risks associated with the cryogenic supply chain for cell therapies, and how supply chain disruptions can best be mitigated.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena