Advanced Bladder Cancerγδ-T-BLADDERNCT07204496
A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer
An observational study of Advanced Bladder Cancer, run by Shanghai 10th People's Hospital.
Trial summary
We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Bladder Cancer
- What is being tested?
- Ex Vivo Expanded γδ T Cell Infusion
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from adult patients (aged 18-75 years) with histologically confirmed, unresectable advanced bladder cancer (AJCC Stage III or IV) who have failed at least two prior lines of standard therapy. The population will include individuals with adequate organ function (hematologic, hepatic, renal, cardiac, and coagulation parameters per predefined criteria) and an ECOG performance status of 0-1. Key exclusions comprise active autoimmune diseases, uncontrolled infections, concurrent malignancies, organ transplant recipients, and significant cardiovascular/neurological comorbidities. This trial specifically targets a population eligible for investigational cellular immunotherapy, focusing on those with progressive disease despite conventional treatments.
Who may be able to join
- The subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.
- Aged 18-75 years, regardless of gender.
- Diagnosed with primary bladder cancer confirmed by histopathology or clinical diagnostic criteria, clinically assessed as unresectable, and having failed at least two prior lines of standard therapy.
- Adequate organ function:
- Hematologic system (no transfusion or hematopoietic growth factor therapy within 14 days prior to enrollment):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
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- Platelets (PLT) ≥60×10⁹/L
- Hemoglobin (Hb) ≥90 g/L
- Liver function:
- Total bilirubin (TBIL) ≤1.5×ULN
- Alanine aminotransferase (ALT) ≤3×ULN
- Aspartate aminotransferase (AST) ≤3×ULN
- Albumin ≥2.8 g/dL
- Coagulation function:
- Activated partial thromboplastin time (APTT) ≤1.5×ULN
- International normalized ratio (INR) or prothrombin time (PT) within normal range
- Renal function:
- Serum creatinine ≤1.5×ULN, or
- Creatinine clearance (Ccr) ≥50 mL/min (calculated using Cockcroft-Gault formula; applies only if creatinine >1.5×ULN)
- Thyroid function:
- Thyroid-stimulating hormone (TSH) ≤1×ULN
- Free triiodothyronine (FT3) ≤1×ULN
- Free thyroxine (FT4) ≤1×ULN
- Cardiovascular function:
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography
- AJCC Bladder Cancer Stage III or IV.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- At least one measurable lesion (according to mRECIST criteria).
- Expected survival time ≥6 months.
- Male subjects with partners of childbearing potential must use reliable and effective contraception from signing the informed consent form until 180 days after the last dose of the study drug. Male subjects with pregnant partners must use condoms and require no additional contraception methods.
Who cannot join
- Prior treatments within 28 days before the first dose:
- Chemotherapy, radiotherapy, biologic therapy, immunotherapy, targeted therapy, local therapy, or traditional Chinese medicine with明确抗肿瘤适应症 (clear antitumor indications).
- Major surgical procedures or failure to recover from side effects of such surgeries (excluding minor procedures, e.g., appendectomy, tumor biopsy).
- Participation in other interventional drug clinical trials (excluding observational studies or survival follow-up).
- Failure to recover from prior antitumor therapy-related toxicities (except alopecia) (i.e., toxicity still > Grade 1 or not returned to baseline).
- Concurrent or history of other malignancies, except:
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- Curative basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Papillary thyroid carcinoma
- Ductal carcinoma in situ of the breast
- Other malignancies with disease-free survival >5 years
- Uncontrolled diabetes despite optimal supportive care.
- Presence of gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome.
- History or presence of autoimmune diseases (e.g., rheumatoid arthritis).
- Neurological diseases, diffuse leptomeningeal disease, or comorbid neurodegenerative disorders.
- History or planned stem cell or organ transplantation during the study.
- Any of the following within 6 months before the first dose:
- Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant thromboembolic events.
- Unstable angina, myocardial infarction, or symptomatic chronic heart failure.
- Ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- Coronary/peripheral artery bypass grafting.
- Current or history of congestive heart failure (NYHA Class II-IV).
- Uncontrolled hypertension despite medication (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg).
- Active infections, including:
- Clinically uncontrolled active infections within 7 days before the first dose (e.g., acute pneumonia, unexplained persistent fever).
- Hepatitis B (HBsAg-positive and HBV-DNA >1000 IU/mL; HBV carriers must receive antiviral therapy per local guidelines and commit to ongoing treatment during the study).
- Hepatitis C (HCV antibody-positive).
- HIV or Treponema pallidum (TP) infection.
- Requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants.
- Pregnancy or lactation.
- Any uncontrolled concurrent condition (including psychiatric disorders or substance abuse) deemed by the investigator to compromise subject cooperation or trial participation, or any other reason making the subject unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Through real-world clinical data, we aim to scientifically determine whether this novel T-cell therapy can significantly alter the pathological progression of tumors and improve patient outcomes. Ultimately, we seek to benefit a broader patient population by achieving long-term tumor-bearing or tumor-free survival, transforming cancer management into a chronic disease model and improving patients' quality of life.
- Conditions
- Advanced Bladder Cancer
- Being tested
- Ex Vivo Expanded γδ T Cell Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex Vivo Expanded γδ T Cell InfusionBiological
This study involves the use of γδ T cell infusion, a non-genetically modified adoptive cellular immunotherapy. The intervention utilizes autologous γδ T cells isolated from peripheral blood and expanded ex vivo using specific activators such as zoledronate and cytokines, without genetic engineering. Its mechanism of action relies on the inherent MHC-unrestricted tumor recognition capability of γδ T cells, activating both the NKG2D-NKG2DL axis and BTN3A1-CD277 pathway for dual antitumor activity. The manufacturing process follows GMP-compliant closed-system conditions, with final product release criteria requiring ≥80% purity for CD3+γδ TCR+ cells, along with sterility testing, endotoxin detection, and cytotoxicity assays. This approach fundamentally differs from genetically modified αβ T cell-based therapies like CAR-T or TCR-T, as well as non-specific immunotherapies such as CIK/DC-CIK, and demonstrates superior ex vivo expansion and tumor-targeting capabilities compared to TIL therap
| Study group | Role | What they receive |
|---|---|---|
| Patients with Advanced Bladder Cancer | Not described Receives: Biological: Ex Vivo Expanded γδ T Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: From the time of randomization (or initiation of treatment) until the occurrence of objective tumor progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start26 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Li, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204496
- Sponsor's protocol ID
- SHSY-IEC-6.0/24K176/P02
- Acronym
- γδ-T-BLADDER
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer
- ClinicalTrials.gov ID
- NCT07204496
- Acronym / sponsor ID
- γδ-T-BLADDER / SHSY-IEC-6.0/24K176/P02
- Conditions
- Advanced Bladder Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 26 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Through real-world clinical data, we aim to scientifically determine whether this novel T-cell therapy can significantly alter the pathological progression of tumors and improve patient outcomes. Ultimately, we seek to benefit a broader patient population by achieving long-term tumor-bearing or tumor-free survival, transforming cancer management into a chronic disease model and improving patients' quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Advanced Bladder Cancer | – | Biological: Ex Vivo Expanded γδ T Cell Infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from adult patients (aged 18-75 years) with histologically confirmed, unresectable advanced bladder cancer (AJCC Stage III or IV) who have failed at least two prior lines of standard therapy. The population will include individuals with adequate organ function (hematologic, hepatic, renal, cardiac, and coagulation parameters per predefined criteria) and an ECOG performance status of 0-1. Key exclusions comprise active autoimmune diseases, uncontrolled infections, concurrent malignancies, organ transplant recipients, and significant cardiovascular/neurological comorbidities. This trial specifically targets a population eligible for investigational cellular immunotherapy, focusing on those with progressive disease despite conventional treatments.
Key inclusion criteria (30 listed)
- The subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.
- Aged 18-75 years, regardless of gender.
- Diagnosed with primary bladder cancer confirmed by histopathology or clinical diagnostic criteria, clinically assessed as unresectable, and having failed at least two prior lines of standard therapy.
- Hematologic system (no transfusion or hematopoietic growth factor therapy within 14 days prior to enrollment):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
Key exclusion criteria (31 listed)
- Chemotherapy, radiotherapy, biologic therapy, immunotherapy, targeted therapy, local therapy, or traditional Chinese medicine with明确抗肿瘤适应症 (clear antitumor indications).
- Major surgical procedures or failure to recover from side effects of such surgeries (excluding minor procedures, e.g., appendectomy, tumor biopsy).
- Participation in other interventional drug clinical trials (excluding observational studies or survival follow-up).
- Failure to recover from prior antitumor therapy-related toxicities (except alopecia) (i.e., toxicity still > Grade 1 or not returned to baseline).
- Curative basal cell or squamous cell skin cancer
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 |
|---|---|---|
| Ex Vivo Expanded γδ T Cell InfusionThis study involves the use of γδ T cell infusion, a non-genetically modified adoptive cellular immunotherapy. The intervention utilizes autologous γδ T cells isolated from peripheral blood and expanded ex vivo using specific activators such as zoledronate and cytokines, without genetic engineering. Its mechanism of action relies on the inherent MHC-unrestricted tumor recognition capability of γδ T cells, activating both the NKG2D-NKG2DL axis and BTN3A1-CD277 pathway for dual antitumor activity. The manufacturing process follows GMP-compliant closed-system conditions, with final product release criteria requiring ≥80% purity for CD3+γδ TCR+ cells, along with sterility testing, endotoxin detection, and cytotoxicity assays. This approach fundamentally differs from genetically modified αβ T cell-based therapies like CAR-T or TCR-T, as well as non-specific immunotherapies such as CIK/DC-CIK, and demonstrates superior ex vivo expansion and tumor-targeting capabilities compared to TIL therap | Biological | Patients with Advanced Bladder Cancer |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the time of randomization (or initiation of treatment) until the occurrence of objective tumor progression or death from any cause, whichever occurs first.
Progression-Free Survival (PFS)
Time frame: From enrollment to the end of treatment at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Bladder Cancer, run by Shanghai 10th People's Hospital.
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 30 inclusion and 31 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: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEI LI, M.D. (86 13817665602, liweitongji@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the time of randomization (or initiation of treatment) until the occurrence of objective tumor progression or death from any cause, whichever occurs first.). The study lists 2 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 2 Oct 2025.