Antitumor T Cell Responses in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

— immunoBLAD  

Official title:

Study of Antitumor T Cell Immune Responses in Patients With Bladder Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334406
• Other study ID #: 098 DRC 210 ER03 012
• Status: Not yet recruiting
• Start date: April 2, 2024
• Est. completion date: April 2, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Jihane Boustani, MD, PhD
• Phone: +33 3 70 63 23 02
• Email: jboustani[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to evaluate the induction of Th1 anti-TERT responses by treatments in patients with bladder tumor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: April 2, 2026
• Est. primary completion date: April 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing transurethral resection of the bladder (TURBT) for a tumor detected by cystoscopy with a histological diagnosis of a non-infiltrating or muscle-infiltrating tumor
• For muscle-invasive tumors: localized tumors (T2-T3N0M0) or locally advanced (T4N0M0)
• Written informed consent

Exclusion Criteria:

• History of TURBT for a bladder tumor whatever the stage
• Stages N1-3 or M1 on initial assessment
• Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone = 10 mg/day is allowed)
• History of cancer in the last 3 years other than basal cell carcinoma or non-invasive cervical cancer
• HIV, hepatitis C or B infection
• Patients with any medical or psychiatric condition or disease,
• Patients under guardianship, curatorship or under the protection of justice.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Biological samples
Blood samples will be collected at baseline, after the diagnostic TURBT, and D15 after the end of treatment in each cohort. Tumor tissues will be collected at baseline for three patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor antigen specific T-cell responses	Increase in the post-treatment sample of at least 30% in the level of anti-TERT Th1 lymphocytes in the blood measured by the ELISpot IFN-? method, compared to the measurement at baseline.	15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary	Monitoring of T cells in the blood	Flow cytometry analysis using T cell markers for : activation (ICOS, CD137, OX40), differenciation (CD45RA, CCR7, CD62L, CD95), cytotoxicity (perforin, granzyme B, GNLY, SlamF7) and exhaustion (PD-1, TIM-3, TIGIT, TCF1, CD39)	15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary	Monitoring of immune cell death parameters in the blood	ATP and HMGB1 by ELISA test	15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary	Monitoring of immune suppressive cells in the blood	Flow cytometry analysis using Treg markers (CD3, CD4, CD25, CD127, Foxp3) and monocytic MDSC (CD14, CD11b, CD33, HLA-DR, and lineage cocktail CD3 CD19 CD56).	15 days after the last instillations (cohort A), 15 days after the end of radiotherapy (cohort B), 15 days after the end of neo-adjuvant chemotherapy (cohort C)
Secondary	Overall survival	Time between the date of diagnosis and the date of death from any cause	Date of death from any cause (within 2 years after the initiation of the treatment)
Secondary	Progression-free survival	Time interval between the date of diagnosis and the date of first progression (local, pelvic, metastatic [extent of the disease by RECIST v1.1]) or death from any cause	date of first progression of the disease (within 2 year after the initiation of the treatment)
Secondary	Local progression-free survival	Time interval between the date of diagnosis and the date of first local progression or death from any cause	date of first local progression of the disease (within 2 year after the initiation of the treatment)
Secondary	Transcriptomic analysis	Expression of genes of the anti-tumor responses in blood and tumor	At baseline