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Streptococcus Pyogenes, Group A, Type 3, Strain Su, Inactivated

This article discusses the ongoing clinical trials investigating TARA-002, a novel treatment for high-grade non-muscle invasive bladder cancer. TARA-002 is an inactivated form of Streptococcus Pyogenes, Group A, Type 3, Strain Su, which is being studied for its potential anti-tumor activity when administered intravesically (directly into the bladder). The trials aim to evaluate the safety, efficacy, and quality of life impacts of this innovative therapy for patients with this challenging form of bladder cancer.

Table of Contents

What is TARA-002?

TARA-002 is an investigational medication being studied for the treatment of high-grade non-muscle invasive bladder cancer. It is a biological product derived from inactivated Group A Streptococcus pyogenes, specifically type 3, strain SU[1]. This medication is administered directly into the bladder, a method known as intravesical instillation.

Medical Condition: Non-Muscle Invasive Bladder Cancer

Non-muscle invasive bladder cancer (NMIBC) is a type of bladder cancer that has not spread into the muscle layer of the bladder wall. High-grade NMIBC is a more aggressive form of this cancer. The clinical trial focuses on patients with high-grade non-muscle invasive carcinoma in situ (CIS), which is a flat, high-grade cancer confined to the inner layer of the bladder[1].

How TARA-002 Works

While the exact mechanism of action is not fully described in the trial information, TARA-002 is likely designed to stimulate the immune system to fight cancer cells in the bladder. As a biological product derived from inactivated bacteria, it may work similarly to other immunotherapies used in bladder cancer treatment[1].

Clinical Trial Overview

The clinical trial for TARA-002 is a Phase 1b/2 study, which means it is in the early stages of testing in humans. The main objectives of the trial are:

  1. To assess the safety of TARA-002 when administered into the bladder
  2. To evaluate the anti-tumor activity (effectiveness) of TARA-002
  3. To study changes in cytokine levels (proteins involved in immune responses) after treatment
  4. To assess the quality of life of patients receiving the treatment[1]

Eligibility Criteria

To participate in the trial, patients must meet certain criteria, including:

  • Being 18 years or older
  • Having a confirmed diagnosis of high-grade non-muscle invasive CIS
  • For some parts of the study, having cancer that has not responded to or has returned after previous treatment with BCG (a standard immunotherapy for bladder cancer)
  • Not having certain medical conditions or a history of other cancers[1]

Treatment Process

TARA-002 is administered directly into the bladder through a process called intravesical instillation. Patients are typically asked to hold the medication in their bladder for about 2 hours to allow it to work effectively[1].

Potential Benefits

The potential benefits being studied include:

  • Reduction or elimination of cancer cells in the bladder (complete response)
  • Longer periods without cancer recurrence
  • Improved survival rates
  • Delay or avoidance of more invasive treatments like bladder removal (cystectomy)[1]

Safety Considerations

As with any experimental treatment, there may be risks and side effects. The trial is designed to carefully monitor for any adverse events. Patients with a penicillin allergy are excluded from the study due to the bacterial origin of TARA-002[1].

Quality of Life Assessment

An important aspect of this trial is the assessment of patients’ quality of life. This is done using standardized questionnaires (EORTC QLQ-C30 and QLQ-NMIBC24) that help researchers understand how the treatment affects patients’ daily lives and overall well-being[1].

Aspect Details
Study Type Phase 1b/2, dose expansion, open-label study
Treatment TARA-002 (inactivated Streptococcus Pyogenes) administered intravesically
Target Condition High-grade non-muscle invasive bladder cancer (CIS ± Ta/T1)
Study Cohorts Cohort A: BCG-naïve or >24 months since BCG
Cohort B: BCG-unresponsive CIS
Primary Endpoints Incidence of high-grade complete response at any time
Secondary Endpoints Safety profile, cytokine level changes, quality of life, duration of response, progression-free survival, overall survival
Follow-up Duration Up to 24 months
Key Eligibility Criteria Adults 18+, confirmed high-grade NMIBC, adequate organ function, no significant urinary incontinence
Key Exclusion Criteria Penicillin allergy, predominant non-urothelial histology, nodal or metastatic disease, history of ≥T2 bladder cancer

FAQ

  • What is TARA-002 and how is it administered? TARA-002 is a medical treatment derived from inactivated Streptococcus Pyogenes bacteria. It is administered intravesically, which means it is directly instilled into the bladder through a catheter.
  • What type of cancer is being targeted in these clinical trials? The clinical trials are focusing on high-grade non-muscle invasive bladder cancer, particularly carcinoma in situ (CIS) with or without Ta/T1 tumors.
  • Who is eligible to participate in these trials? Eligible participants are adults (18 years or older) with confirmed high-grade non-muscle invasive CIS. The trials include two cohorts: one for patients who cannot access BCG treatment or haven't received it in 24 months, and another for patients with BCG-unresponsive CIS.
  • What are the main objectives of the clinical trials? The main objectives are to assess the anti-tumor activity, safety profile, and efficacy of TARA-002 when administered intravesically. The trials also aim to evaluate changes in cytokine levels and quality of life in patients receiving the treatment.
  • How long will patients be followed in these trials? Patients will be followed for up to 24 months, with assessments of complete response rates, progression-free survival, and overall survival at various time points throughout the study.

Ongoing Clinical Trials on Streptococcus Pyogenes, Group A, Type 3, Strain Su, Inactivated

  • Study on the Safety and Effectiveness of TARA-002 for Adults with High-Grade Non-Muscle Invasive Bladder Cancer

    Not yet recruiting

    1 1
    Investigated drugs:
    Romania Spain

Glossary

  • Intravesical: A method of administering medication directly into the bladder, typically through a catheter.
  • Non-muscle invasive bladder cancer (NMIBC): A type of bladder cancer that has not spread into the muscle layer of the bladder wall.
  • Carcinoma in situ (CIS): A very early form of cancer that is still confined to the layer of cells where it began and has not spread to other tissues.
  • BCG: Bacillus Calmette-Guérin, a type of immunotherapy commonly used to treat non-muscle invasive bladder cancer.
  • TURBT: Transurethral resection of bladder tumor, a surgical procedure to remove bladder tumors.
  • Cytokine: Small proteins released by cells that have specific effects on the interactions and communications between cells.
  • Complete Response (CR): The disappearance of all signs of cancer in response to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Quality of Life (QoL): A measure of an individual's well-being and ability to carry out daily activities while dealing with a medical condition or its treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-tara-002-for-adults-with-high-grade-non-muscle-invasive-bladder-cancer/