A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer

NCT07204496 | Not Yet Recruiting DMC

• 1 other identifier: SHSY-IEC-6.0/24K176/P02
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  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)

  From enrollment to the end of treatment at 30 days

Study Arms (1)

Patients with Advanced Bladder Cancer

Biological: Ex Vivo Expanded γδ T Cell Infusion

Interventions

Ex Vivo Expanded γδ T Cell Infusion BIOLOGICAL

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

Patients with Advanced Bladder Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Central Study Contacts

WEI LI, M.D.

CONTACT

86 13817665602; liweitongji@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 2, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL