Recurrent or Metastatic Bladder CancerEarly Phase 1NCT05559177
An Open, Dose-escalation Clinical Study of Chimeric Exosomal Tumor Vaccines for Recurrent or Metastatic Bladder Cancer
A Early Phase 1 study testing Chimeric exosomal tumor vaccines in people with Recurrent or Metastatic Bladder Cancer, run by Shanghai Pudong Hospital at 1 site in China.
Trial summary
1. Based on the applicant's previous work and combined with the clinical medical resources of our unit, tumor cells were isolated from the lesion site of cancer patients, dendritic cells or macrophages were isolated from peripheral blood, and personalized chimeric exosome vaccine was prepared for patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Recurrent or Metastatic Bladder Cancer
- What is being tested?
- Chimeric exosomal tumor vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bladder cancer confirmed by histopathology and/or cytology;
- Age ≥18 years old and ≤85 years old, both sexes;
- ECOG score of general physical condition 0 ~ 2 points;
- The expected survival time is at least 3 months.
- Lack of conventional effective treatment, failure or recurrence after conventional treatment (surgery, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, etc.), or refusal of conventional treatment;
- According to RECIST criteria, at least one measurable objective tumor index (target lesion ≥10mm detected by spiral CT);
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- At baseline, WBC≥3.5×109/L, Hb≥90g/L, PLT≥80×109/L;
- Subjects must have adequate organ function and the following laboratory tests during the screening period must be met:
- Absolute neutrophil count (ANC)≥1.5×109 /L, platelet (PLT)≥ 80×109 /L, hemoglobin (Hb)≥ 85g/L;
- Serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values;
- Serum total bilirubin (TBIL) ≤ 2 times of the upper limit of normal;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal values; Subjects with liver metastases were no more than 5 times the upper limit of normal;
- Activated partial thromboplastin time (APTT) and prothrombin time (PT) were within 1.5 times of the upper limit of normal values;
- Eligible fertile patients (male and female) must consent to use a reliable contraceptive method (hormonal or barrier or abstinence) with their partner during the trial and for at least 180 days after the last dose; Women of childbearing age must have a negative urinary pregnancy test within 7 days before enrollment;
- Subject signed informed consent voluntarily and expected compliance was good.
Who cannot join
- Severe infection and other serious complications;
- The patient has a previous or current primary malignancy associated with other sites, excluding effectively treated non-malignant melanoma skin cancer, carcinoma in situ of the cervix, or other malignancy that has been potentially curable with effective treatment and has been in remission for at least 5 years;
- Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, but not vitiligo;
- Patients with systemic corticosteroid or other immunosuppressive hormone therapy can be treated with prednisone < 0.5 mg/kg/day (maximum cell number group 40 mg/day) or other similar drugs in the equivalent cell number group, inhaled corticosteroid hormones can be used for chronic obstructive pulmonary disease (COPD) or topical use
- Patients who have undergone major organ transplants;
- Patients with active bleeding or severe coagulopathy;
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- Patients with active pulmonary tuberculosis and strong positive OT test;
- Patients with previous severe interstitial lung changes (as determined by the investigator);
- Subjects with any severe and/or uncontrolled disease, including:
- poor control of hyperbole (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥100mmHg);
- Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc≥ 450ms in men and QTc≥470ms in women), and congestive heart failure grade ≥2 (NYHA classification);
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency;
- Urine routine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantification > 1.0 g;
- Four weeks before the first drug administration, antitumor therapy was performed, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor Chinese medicine therapy; For subjects receiving nitrolurea and mitomycin chemotherapy, discontinuation was within 6 weeks;
- Had received a prophylactic or attenuated or therapeutic vaccine within 4 weeks before the first dose;
- Toxicity after previous antitumor therapy has not recovered to CTCAE 5.0 grade 0 or level 1;
- Current active hepatitis B, active hepatitis C, immunodeficiency virus, or other active infection of clinical significance;
- Patients who had undergone tertiary surgery or unhealed surgical wounds 4 weeks before enrollment;
- Participated in other clinical trials within four weeks before enrollment;
- Pregnant or lactating women and those who plan to give birth within six months (male or female);
- In the judgment of the investigator, the subject is not suitable to participate in the trial for any reason -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Pudong Medical Center
Shanghai, 201399
Jun Ren, 13911568563, jun.ren@duke.edu
About this study
- Based on the applicant's previous work and combined with the clinical medical resources of our unit, tumor cells were isolated from the lesion site of cancer patients, dendritic cells or macrophages were isolated from peripheral blood, and personalized chimeric exosome vaccine was prepared for patients.
- To evaluate the safety and tolerability of multiple administration of chimeric exosome vaccine in subjects with hatching or metastatic bladder cancer, explore the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) in humans, and recommend the safe dose range for the subsequent extended trials and subsequent clinical studies of this product.
- To reveal the "double-effect" improvement mechanism of chimeric exosome vaccine on the activation of immune response and the microenvironment of bladder cancer lesions, improve the anti-recurrence treatment effect of bladder cancer, and realize the clinical transformation of "double-target and double-effect" chimeric exosome vaccine in the field of individualized precision treatment of bladder cancer patients.
- To explore the clinical application value of this tumor therapeutic vaccine by using the T-cell receptor immunoomics and immunomolecular evaluation technology platform established by previous researchers, and to provide preliminary clinical research results for further vaccine development.
- Conditions
- Recurrent or Metastatic Bladder Cancer
- Being tested
- Chimeric exosomal tumor vaccines
- Medical subject headings
- Recurrence, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric exosomal tumor vaccinesBiological
Tumor cells (lesion site) were isolated from bladder cancer patients, and bladder cancer nuclei were extracted. Monocytes were isolated from peripheral blood of this patient and induced in vitro to obtain APC (DC or macrophage). Apc-tumor chimeric cells were constructed and stimulated with immune stimulator. Chimeric exosomal vaccines were extracted from cell supernatants by differential and hypervelocity centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Treatment of recurrent or metastatic bladder cancer | Experimental | Lack of conventional effective treatment, failure or recurrence of treatment with conventional methods (surgery, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, etc.), or refusal of conventional treatment Receives: Biological: Chimeric exosomal tumor vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
The percentage of patients with CR and PR in the total number of patients in the same period
Measured: 24 months
Overall survival(OS)
From the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first
Measured: 24 months
Safty(adverse events)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559177
- Sponsor's protocol ID
- FDZJ-01
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose-escalation Clinical Study of Chimeric Exosomal Tumor Vaccines for Recurrent or Metastatic Bladder Cancer
- ClinicalTrials.gov ID
- NCT05559177
- Acronym / sponsor ID
- FDZJ-01
- Conditions
- Recurrent or Metastatic Bladder Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Based on the applicant's previous work and combined with the clinical medical resources of our unit, tumor cells were isolated from the lesion site of cancer patients, dendritic cells or macrophages were isolated from peripheral blood, and personalized chimeric exosome vaccine was prepared for patients.
- To evaluate the safety and tolerability of multiple administration of chimeric exosome vaccine in subjects with hatching or metastatic bladder cancer, explore the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) in humans, and recommend the safe dose range for the subsequent extended trials and subsequent clinical studies of this product.
- To reveal the "double-effect" improvement mechanism of chimeric exosome vaccine on the activation of immune response and the microenvironment of bladder cancer lesions, improve the anti-recurrence treatment effect of bladder cancer, and realize the clinical transformation of "double-target and double-effect" chimeric exosome vaccine in the field of individualized precision treatment of bladder cancer patients.
- To explore the clinical application value of this tumor therapeutic vaccine by using the T-cell receptor immunoomics and immunomolecular evaluation technology platform established by previous researchers, and to provide preliminary clinical research results for further vaccine development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of recurrent or metastatic bladder cancer | Experimental | Biological: Chimeric exosomal tumor vaccinesLack of conventional effective treatment, failure or recurrence of treatment with conventional methods (surgery, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, etc.), or refusal of conventional treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with bladder cancer confirmed by histopathology and/or cytology;
- Age ≥18 years old and ≤85 years old, both sexes;
- ECOG score of general physical condition 0 ~ 2 points;
- The expected survival time is at least 3 months.
- Lack of conventional effective treatment, failure or recurrence after conventional treatment (surgery, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, etc.), or refusal of conventional treatment;
Key exclusion criteria (22 listed)
- Severe infection and other serious complications;
- The patient has a previous or current primary malignancy associated with other sites, excluding effectively treated non-malignant melanoma skin cancer, carcinoma in situ of the cervix, or other malignancy that has been potentially curable with effective treatment and has been in remission for at least 5 years;
- Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, but not vitiligo;
- Patients with systemic corticosteroid or other immunosuppressive hormone therapy can be treated with prednisone < 0.5 mg/kg/day (maximum cell number group 40 mg/day) or other similar drugs in the equivalent cell number group, inhaled corticosteroid hormones can be used for chronic obstructive pulmonary disease (COPD) or topical use
- Patients who have undergone major organ transplants;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimeric exosomal tumor vaccinesTumor cells (lesion site) were isolated from bladder cancer patients, and bladder cancer nuclei were extracted. Monocytes were isolated from peripheral blood of this patient and induced in vitro to obtain APC (DC or macrophage). Apc-tumor chimeric cells were constructed and stimulated with immune stimulator. Chimeric exosomal vaccines were extracted from cell supernatants by differential and hypervelocity centrifugation | Biological | Treatment of recurrent or metastatic bladder cancer |
Primary outcome
Clinical response rate
Time frame: 24 months
The percentage of patients with CR and PR in the total number of patients in the same period
Overall survival(OS)
Time frame: 24 months
From the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first
Safty(adverse events)
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chimeric exosomal tumor vaccines in people with Recurrent or Metastatic Bladder Cancer, run by Shanghai Pudong Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Ren (13911568563, jun.ren@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.