NCT04963959

PBMC Collection for Production of UCAR T Cells

A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for UCAR T Production and Clinical Investigation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and production of UCAR T cells used for Clinical trails.

Detailed description

The study is a single-center study. 1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled. 2. Apheresis period: 25 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.

Conditions

• Peripheral Blood Mononuclear Cell

Interventions

Type	Name	Description
DEVICE	Peripheral blood mononuclear cell apheresis	mononuclear cell donation for tumor immunotherapy study of UCAR-T cells

Timeline

• Start date: 2021-07-14
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-07-15
• Last updated: 2021-11-04

Locations

1 site across 1 country: China