Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

Healthy Volunteers Clinical Trial

— SMART101-HV1  

Official title:

Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118113
• Other study ID #: SI101-HV1
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Smart Immune SAS
• Contact: Aurelie Bauquet, PhD
• Phone: +33 (0) 671709793
• Email: aurelie.bauquet[@]smart-immune.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy donors, men aged 18 to 40 years.

• Body weight = 65 kg with a body mass index (BMI) calculated by weight in kg/(height in m)² of 20 to 30 kg/m² at screening.

• Informed consent form signed and dated prior to any study-specific screening procedure.

• Health status judged by the investigator to be compatible with participation in the study based on medical history, results of physical examination, results of biological laboratory tests (cell blood count including RBC, hematocrit, hemoglobin, reticulocytes, WBC, platelet, PT, aPTT, CRP, fasting blood glucose, ionogram (Na+, K+, Cl-, HCO3-), creatinine, creatinine clearance by Cockcroft, albumin, total protein, total bilirubin, AST, ALT, ALP, GGT), vital signs measurements and 12-lead ECG. All results should be normal or, if out of range, clinically insignificant in the judgement of the investigator.

• Venous capital compatible with leukapheresis

• Have a high probability of complying with and completing the study.

• Be affiliated with a Social Security scheme

Exclusion Criteria:

• Any cardiovascular (e.g. heart failure), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunological, dermatological, haematological (including hemoglobinopathy), neurological, psychiatric disorder or any history of allergy to a drug.

• State of acute illness (e.g., vomiting, fever, diarrhea) within 7 days prior to the first day of the study.

• History of drug abuse in the year preceding the first day of the study.

• History of alcoholism in the year prior to day 1 defined as consumption of more than 3 standard drinks/day (30 g/day) or 15 standard drinks/week (150 g/week) or less than two non-alcoholic days each week, or more than 5 standard drinks (50 g) on a single occasion.

• Any contra-indication to filgrastim

• Positive serological results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, syphilis and/or human T-lymphotropic virus (HTLV).

• Positive urine drug tests (methadone, barbiturates, benzodiazepines, tricyclic antidepressants, cocaine, cannabinoids, morphine, amphetamines and methamphetamines, including 3,4-methylenedioxy-N-methylamphetamine [MDMA]).

• Laboratory workup including blood count, fasting blood glucose, blood ionogram, creatinine, AST, ALT, gamma GT, alkaline phosphatase, total bilirubin, CRP, PT, aPTT incompatible with leukapheresis protocol.

• Use of any experimental drug within 30 days prior to inclusion.

• Use of any prescription or over-the-counter medication within 5 times the elimination half-life prior to inclusion. However, any prescribed medication that may interfere with the study objectives must be discontinued for at least 30 days.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers
Mobilisation of hematopoietic stem cells by injection of filgrastim (authorized auxiliary medicinal product) for 4 consecutive days and leukapheresis on Day 5

Locations

Country	Name	City	State
France	CIC Paris Est, Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Smart Immune SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of cell therapy products fulfilling the required specifications	Production of cell therapy products fulfilling the required specifications after 7 days of CD34+ cell culture	7 days