Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus

NCT01325636 | Completed Phase 1 DMC

• 1 other identifier: P090801
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this project is to evaluate the efficiency of the injection of CD4 and CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the first injection (adenovirus infection is not enough usual, especially in adults, to be used for the primary purpose and is measured in the secondary endpoints).

Conditions

Cytomegalovirus Infections; Adenovirus Infections

Keywords

Allogenic haematopoietic stem cell transplant; Cytomegalovirus or Adenovirus infection; Graft versus Host

Outcome Measures

Primary Outcomes (1)

• CMV blood viral load by PCR

  at day 21

Secondary Outcomes (3)

• GvHa evaluation

  at week 1, 2 ,3 ,4 and at month 1, 2, 3, 4, 5, 6

• Evaluation of clinical signs according to interested organs (lung, liver, bowel,…)

  at week 1, 2 ,3 ,4 and at month 1, 2, 3, 4, 5, 6

• Increase of T cells

  at week 1, 2 ,3 ,4, 6, 8, 10, 12 and at month 3, 4, 5, 6

Study Arms (1)

CD4 and CD8 T cell

EXPERIMENTAL

Injection of specific CD4 and CD8 T cell

Other: Cell therapy

Interventions

Cell therapy OTHER

Injection of specific T cell by intravenous way with a posology of 1000 to 5000 CD3 IFN γ+ / kg. A second injection could be made at day 21

Also known as: Specific CD4 and CD8 T cell

CD4 and CD8 T cell

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• having biological signs (blood viral load) associated or not with clinical signs of infection by CMV and / or resistant or intolerant Adenovirus (myelotoxicity or nephrotoxicity) to a conventional antiviral treatment
• or with CMV or ADV disease with organ damage documented without systemic replication (if possible, with a CMV PCR or ADV PCR positive in the organ)
• answering to eligibility criteria for the donor (in particular donor CMV positive serology and absence of intercurrent infections)
• having been informed - he or his legal representative - and having signed the informed consent
• patient member or benefiting from a social security scheme

You may not qualify if:

• donor CMV negative serology (in the case of anti-CMV immunotherapy). Note : all donors are considered as having met the adenovirus and the status serology towards this virus, will not be checked.
• GvHa \> II and/or requiring a corticosteroid therapy \> 0,5 mg/kg/day and/or a treatment by monoclonal antibody anti-rIl2 could not be interrupted or other immunosuppressor treatment which could potentially interfere with the survival of injected T cell (Thymoglobuline, Campath etc)
• severe organ failure involving the patient's vital prognostic in the short term
• rejection of sample from the donor

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Biotherapy department, Hôpital Necker - Enfants Malades

Paris, 75743, France

Location

Related Publications (1)

• Creidy R, Moshous D, Touzot F, Elie C, Neven B, Gabrion A, Leruez-Ville M, Maury S, Ternaux B, Nisoy J, Luby JM, Heritier S, Dalle JH, Ouachee-Chardin M, Xhaard A, Thomas X, Chevallier P, Souchet L, Treluyer JM, Picard C, Hacein-Bey-Abina S, Dal Cortivo L, Blanche S, Cavazzana M. Specific T cells for the treatment of cytomegalovirus and/or adenovirus in the context of hematopoietic stem cell transplantation. J Allergy Clin Immunol. 2016 Sep;138(3):920-924.e3. doi: 10.1016/j.jaci.2016.03.032. Epub 2016 Apr 30. No abstract available.

  PMID: 27246524 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections; Adenoviridae Infections

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Marina CAVAZZANA, ph

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: September 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (1)