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Safety and Efficacy Study of Virus Activated Killer Immune Cells (VAK) for Malignant Pleural and Peritoneal Effusion

NCT05565014 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-10-04

No results posted yet for this study

Summary

Theory of VAK：

1. Immune cells (T cells for example) of cancer subjects may be domesticated by the tumor microenvironment, and have low efficacy to kill cancer cells. They could be restimulated by virus antigen, and play a powerful tumor killing role while intrapleural to subjects.
2. Releasing of tumor-associated antigen could induce specific anti-tumor immune response.

Preparation of VAK：

1. Separate the immune cells and tumor cells from Malignant Pleural and Peritoneal Effusion.
2. Incubate the immune cells with inactivated viruses and tumor cells.
3. Wash to remove impurities.
4. Intrapleural the immune cells to patients

Conditions

  • Malignant Pleural Effusion
  • Malignant Peritoneal Effusion

Interventions

DRUG

Virus Activated Killer immune Cells

The VAK made from Pleural Effusion should be given to treat Malignant Pleural Effusion.The VAK made from Peritoneal Effusion should be given to treat Malignant Peritoneal Effusion.

DRUG

Saline

The use of saline was the same as VAK group.

Sponsors & Collaborators

  • Binhui Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sheng Hu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565014 on ClinicalTrials.gov