Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 5:47 PM
Study NCT ID:
NCT04963959
Status:
UNKNOWN
Last Update Posted:
2021-11-04
First Post:
2021-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PBMC Collection for Production of UCAR T Cells
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for UCAR T Production and Clinical Investigation
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: