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T Lymphocytes (LT) Expressing iCASP9 and ΔCD19 in Allogeneic Haematopoietic Transplantation.

NCT02849886 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-07-09

No results posted yet for this study

Summary

This study evaluates the frequency of occurrence, severity, and response to treatment by a chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case of acute Graft versus Host Disease (aGvHD) occurring after the administration of T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and T-lymphocytes

Conditions

Interventions

DRUG

T lymphocytes iCASP9 ΔCD19

Intravenous injection of the T lymphocytes armed with the iCASP9 suicide gene

DRUG

Dimerizer drug AP1903

AP1903 drug will be administrated at a dose of 0.4 mg/kg by intravenous route in the two following cases: * Acute Grade ≥II or symptomatic Grade I GvHD justifying systemic immunosuppression therapy; * Grade ≥3 toxicity attributable to GMC.

Sponsors & Collaborators

  • Etablissement Français du Sang

    collaborator OTHER

  • Bellicum Pharmaceuticals

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • DECONINCK Eric, MD, PhD, HDR · CHRU de Besançon

  • Christophe FERRAND, PhD, HDR · EFSBFC-INSERM UMR1098

  • Marina DESCHAMPS, PhD · EFSBFC-INSERM UMR1098

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2021-12-26
Completion
2021-12-26

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02849886 on ClinicalTrials.gov