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Phase I Study of PPM Therapy for Non-muscle-invasive Bladder Cancer

This clinical trial is testing a new treatment called PLZ4-coated paclitaxel-loaded micelles (PPM) for non-muscle-invasive bladder cancer (NMIBC). PPM uses tiny particles to deliver the chemotherapy drug paclitaxel directly to bladder cancer cells. This treatment is for patients whose bladder cancer has not spread into the muscle layer and has not responded to a previous treatment called BCG. The study aims to find the safest and most effective dose of PPM, understand its side effects, and gather early information on how well it works. Up to 29 patients will participate. The treatment is given directly into the bladder.

Study design
This is a Phase I interventional study with a planned enrollment of 29 participants. It is designed to evaluate the safety and preliminary effectiveness of the treatment.
What's involved
Participants will receive PPM administered weekly for 6 times through intravesical instillation into the bladder cavity. The biopsy must be done within 3 months of enrollment and a cystoscopy within 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured for up to 6 weeks after the last dose of treatment.

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

NCT05519241

A Phase I Intravesical PPM Therapy for NMIBC

Recruiting
PHASE1Ages 18+InterventionalTreatment
VA Office of Research and Development
~29 participants
Updated 2026-08-17 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
adverse events
Measured over up to 6 weeks after the last dose

Conditions

Non-muscle-invasive Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT05519241

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.

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusettsstudy 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

  • Chong-Xian Pan, MD PhD · PRINCIPAL_INVESTIGATOR · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Who to contact

Chong-Xian Pan, MD PhD
[email protected]
(857) 203-6189
Email the study team

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Eligibility criteria

Inclusion

Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer. Patients are eligible if the biopsy was done within 3 months of enrollment and a cystoscopy demonstrates no gross disease invasion into muscularis propria within 4 weeks of enrollment.
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 6 months of completion of adequate BCG therapy
T1 high-grade disease at the first evaluation following an induction BCG course
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 urologic guidelines
Performance status: ECOG performance status of 0, 1, or 2 or Karnofsky performance status of 50 or higher
Patient with life expectancy greater than 24 months
No concurrent radiotherapy, chemotherapy, or other immunotherapy
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 participating urologist
Laboratory tests performed within 14 days of study enrollment:
Absolute neutrophil count (AGC/ANC)1,500/uL
Platelets100,000/uL \[Patients may be transfused to meet this requirement\]
Hemoglobin 8 g/dL \[Patients may be transfused to meet this requirement\]
Calculated glomerular filtration rate (GFR) 50 mL/min/1.73m2
Total bilirubin 2.0 X ULN (\< 3 x ULN for patients with Gilbert's syndrome)
AST, ALT, ALP 3.0 X ULN
Adequate pulmonary function with no clinical signs of severe pulmonary dysfunction
Negative serum pregnancy test if the study participant is a female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized)
Female participants of childbearing potential must adhere to using a medically accepted method of birth control, i.e. a tubal ligation, an approved hormonal contraceptive or an intrauterine device, prior to screening and agree to continue its use during the study and up to 3 months after finishing this study or be surgically sterilized (e.g., hysterectomy or tubal ligation). Males must agree to use barrier methods of birth control while on study
Provide signed informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

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 (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 anti-inflammatory 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 nursing
Psychiatric illness/social situations that would limit compliance with study requirements
Other illness that in the opinion of the investigator would exclude the patient from participating in this study
Any other malignancy diagnosed within 3 years of trial entry with the exception of:
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.
Patients unwilling to or unable to comply with the protocol
Patients with impaired decision-making capacity

What this trial measures

  • adverse eventsup to 6 weeks after the last dose

    Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to determine any adverse events and assess the grade. All toxicity as well as Grade 3 or higher adverse events will be analyzed.