Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors (SMART101-HV1)

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Procedure: Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelie Bauquet, PhD; Phone Number: +33 (0) 671709793; Email: aurelie.bauquet@smart-immune.com

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • CIC Paris Est, Hôpital Pitié Salpêtrière
    • Contact: For information on study participation; Phone Number: +33 1 42 17 85 31; Email: secretariat.cic.psl@aphp.fr
    • Principal Investigator: Joe-Elie Salem, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy donors	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Smart Immune SAS
• Investigators: Principal Investigator: Joe-Elie Salem, MD, PhD, CIC Paris Est, Hôpital Pitié Salpêtrière, Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SI101-HV1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No