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PLZ4-Coated Paclitaxel-Loaded Micelles for Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

This study is testing a new treatment called PLZ4-coated paclitaxel-loaded micelles (PPM) for people with non-muscle invasive bladder cancer that has come back or hasn't responded to other treatments. PPM is a special nanoparticle designed to deliver the drug paclitaxel directly to bladder cancer cells. Paclitaxel is a drug that helps kill cancer cells or stop them from growing. The main goal of this study is to see how safe PPM is and if people can tolerate it. Researchers will also look at how well it works to shrink tumors and how long people stay free of cancer. You may be able to join if you have non-muscle invasive bladder cancer that has been confirmed by a biopsy and has not responded to previous treatments like BCG (Bacillus Calmette Guerin). This study plans to enroll 12 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
You would receive PPM directly into your bladder once a week for 6 weeks. You would also have scans (CT, MRI, or PET) and cystoscopies (a procedure to look inside the bladder) with biopsies, and blood tests throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up at 3 weeks, 6 weeks, and then every 3 months for 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06173349

PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, Davis
~12 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:PLZ4-coated paclitaxel loaded micelles (PPM)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment related adverse events
Measured over From first dose of study medication through 12 months after the last dose

Conditions

Recurrent Non-Muscle Invasive Bladder Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT06173349

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California Davis Comprehensive Cancer Center

    Sacramento, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mamta Parikh · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Office of Clinical Research
[email protected]
916-382-6970
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1), determined via transurethral resection of bladder tumor (TURBT) within 3 months of enrollment
Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as being at least one of the following:
Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy
Recurrent high-grade Ta/T1 disease within 12 months of completion of adequate BCG therapy
T1 high-grade disease at the first evaluation following an induction BCG course. In this context, adequate BCG therapy is defined as at least one of the following:
At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per American Urological Association (AUA) guideline
Age ≥ 18 years at time of consent
Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Patient with life expectancy greater than 24 months
No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks
No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation
Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the investigator
Absolute neutrophil count (absolute granulocyte count \[AGC\]/absolute neutrophil count \[ANC\]) ≥ 1,500/µL
Platelets ≥ 100,000/µL (Patients may be transfused to meet this requirement)
Hemoglobin ≥ 8 g/dL (Patients may be transfused to meet this requirement)
Calculated glomerular filtration rate (GFR) ≥ 30 mL/min
Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (\< 3 × ULN for patients with Gilbert's syndrome)
Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN
Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction
Participants of childbearing potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 3 months after last study treatment; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy)
Ability to understand and willingness to sign an informed consent form
Ability and willingness to adhere to the study visit schedule and other protocol requirements

Exclusion

Existence of cancer at the upper urinary tract
Concurrent use of other investigational agents
Evidence of regional and/or distant metastasis
NYHA (New York Heart Association) class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
Symptomatic congestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease)
Patient taking medications that affect coagulation, such as aspirin (though, aspirin 81 mg oral once daily is allowed), Coumadin/Warfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa inhibitors. Other nonsteroidal antiinflammatory drugs (NSAIDs) are allowed as long as they are discontinued the day before therapy
History or evidence of uncontrollable central nervous system (CNS) disease
Active systemic infection requiring parenteral antibiotic therapy
Women who are pregnant or breast feeding
Any other malignancy diagnosed within 3 years of trial entry with the exception of the following:
Basal or squamous cell skin cancers, or
Noninvasive cancer of the cervix, or
Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period, such as localized prostate cancer after definitive treatment and prostate-specific antigen (PSA) less than 0.2 ng/mL
Any condition that would prohibit the understanding or rendering of informed consent
Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

What this trial measures

  • Treatment related adverse eventsFrom first dose of study medication through 12 months after the last dose

    Number of participants experiencing treatment-related AEs, classified by severity and graded according to the NCI CTCAE v5.0