NCT04963959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

July 14, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

November 4, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

July 6, 2021

Last Update Submit

November 3, 2021

Conditions

Peripheral Blood Mononuclear Cell

Outcome Measures

Primary Outcomes (1)

  • The number of peripheral blood mononuclear cells (PBMC

    2 year

Study Arms (1)

Healthy donor

OTHER
Device: Peripheral blood mononuclear cell apheresis

Interventions

Peripheral blood mononuclear cell apheresisDEVICE

mononuclear cell donation for tumor immunotherapy study of UCAR-T cells

Healthy donor

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers who signed informed consent form
  • Age ≥ 18 years and ≤ 40 years, male or female, Han nationality.
  • Weight: male ≥ 50 kg, female ≥ 45 kg; 18.5 ≤ BMI ≤ 30.
  • Temperature: 36.3-37.2℃ (Forehead temperature).

You may not qualify if:

  • Those with known respiratory, circulatory, digestive, urinary, blood, immune, endocrine disorders or metabolic disorders, neurological diseases, mental illnesses and those with a family history;
  • Those with known chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
  • Those with known allergic diseases or recurrent allergies;
  • Those with known malignant tumors or health-affecting benign tumors;
  • Two or more physical examination results of blood pressure have shown (except for white coat hypertension): systolic blood pressure \< 90 or ≥140mmHg, or diastolic blood pressure \< 60 or ≥ 90 mmHg, or pulse pressure \< 30 mmHg, heart rate: \< 60 beats/min or \>100 beats/min;
  • Laboratory tests: hemoglobin is abnormal and has clinical significant; liver and kidney function are higher than the normal upper limit and have clinical significance; 12-lead ECG is abnormal and has clinical significance, or abdominal ultrasound is abnormal and has clinical significance, or chest X-ray is abnormal and has clinical significance; abnormal coagulation function; increased CRP;
  • Those with active or latent hepatitis B or active hepatitis C, or Treponema pallidum antibody, or human immunodeficiency virus antibody, or anti-EBV IgM antibody, or anti-CMV IgM antibody, or COVID-19 DNA ;
  • Recipients of allogeneic tissue and organ or hematopoietic stem cell transplants;
  • Those who have undergone resection of vital internal organs such as stomach, kidney, spleen and lung;
  • Those who have undergone minor surgery within last 3 months, such as appendectomy and ophthalmic surgery; those who have undergone major surgery within 1 year, such as surgical treatment for gynecological benign tumors or superficial benign tumors;
  • Women who are pregnant, or have an abortion within last 6 months or gave childbirth within 1 year;
  • Those whose upper respiratory tract infection has recovered for less than 1 week, or pneumonia has recovered for less than 3 months;
  • Those whose acute pyelonephritis has recovered for less than 3 months, or those with acute exacerbation of urinary calculi;
  • Those who have been injured or wound-contaminated by equipment contaminated by blood or tissue fluids, or who have got a tattoo for less than 1 year;
  • Those who have received whole blood and blood component transfusion within 1 year;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Central Study Contacts

chengcheng Fu

CONTACT

+86 13962191404fuchengchengsz@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 15, 2021

Study Start

July 14, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

November 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)