NCT05559177

An Open, Dose-escalation Clinical Study of Chimeric Exosomal Tumor Vaccines for Recurrent or Metastatic Bladder Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Pudong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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. 3. 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. 4. 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

Interventions

Type	Name	Description
BIOLOGICAL	Chimeric exosomal tumor vaccines	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

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2022-09-29
• Last updated: 2022-09-29

Locations

1 site across 1 country: China