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

NCT05118113 | Unknown

• 1 other identifier: SI101-HV1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy donors

OTHER

Procedure: Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers

Interventions

Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers PROCEDURE

Mobilisation of hematopoietic stem cells by injection of filgrastim (authorized auxiliary medicinal product) for 4 consecutive days and leukapheresis on Day 5

Healthy donors

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smart Immune SAS: lead

Study Sites (1)

CIC Paris Est, Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Study Officials

• Joe-Elie Salem, MD, PhD

  CIC Paris Est, Hôpital Pitié Salpêtrière, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelie Bauquet, PhD

CONTACT

+33 (0) 671709793; aurelie.bauquet@smart-immune.com

Study Design

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

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 11, 2021
• Study Start: April 26, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)