Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients

NCT04018261 | Completed Phase 1

• 1 other identifier: BST-LT-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

Marrow transplanted immunocompromised patients with cytomegalovirus (CMV) viral infection will be treated with CMV activated T-Lymphocytes. T-Lymphocytes will be obtained through an apheresis from a compatible donor. Safety and immunoreconstitution parameters in blood samples will be assessed up to +60 days after the treatment.

Conditions

CMV Viremia; Immunosuppression-related Infectious Disease

Keywords

CMV; Bone marrow transplant; Activated T-Lymphocytes; Cell therapy; Virus infection; immunosuppression

Outcome Measures

Primary Outcomes (1)

• Safety assessment: Adverse events

  Adverse events

  60 days

Secondary Outcomes (5)

• Polymerase chain reaction (PCR)

  +7, +14, +21, +28, +45, +60 days

• IFN-γ+ spot forming cells

  +7, +14, +28, +60 days

• Lymphocyte subpopulations

  +7, +14, +28, +60 days

• T-cell persistence by chimerism

  +14, +28 days

• Time elapsed in identifying the donor

  Day 0

Study Arms (1)

Activated T-Lymphocytes

EXPERIMENTAL

Allogeneic T-Lymphocytes obtained from apheresis activated against CMV.

Drug: Activated T-Lymphocytes

Interventions

Activated T-Lymphocytes DRUG

Activated T-Lymphocytes will be infused intravenously in a single-dose

Activated T-Lymphocytes

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
• Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
• Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
• Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia) It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn't decrease in \> 1 log in total blood or otherwise the absolute number of copies \> 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
• Patients with reactivation of recurrent CMV despite correct anti-CMV treatment. It will be considered a recurrent CMV infection if the patient has \> 2 reactivations in a period \<6 months despite having received correct anti-CMV treatment
• Documented genetic mutations associated with ganciclovir or foscarnet resistance
• ≥ 1 year of age
• Estimated life expectancy \> 30 days
• Signature of the informed consent form

You may not qualify if:

• Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
• Corticosteroid ≥ 0.5mg/kg regardless the indication
• Disease relapse at the time of infection or at any time after the Allogeneic transplant.
• Severe renal disease (creatinine \> 3gr/dL)
• Severe hepatic disease (bilirubin \>3mg/dL or aspartate aminotransferase (AST) \>500 U/L) except if it is secondary to the viral infection.
• Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
• Known hypersensitivity to murine proteins or iron dextran.
• Positive serology to human immunodeficiency virus (HIV), hepatitis B virus (HBV) (HBsAg, HBcAc), hepatitis C virus (HCV) and/or syphilis
• Pregnant, lactating or women without adequate contraception
• Participation in a clinical trial with investigational medicinal products the last 30 days

Sponsors & Collaborators

• Banc de Sang i Teixits: lead
• Vall d'Hebron Institute of Oncology: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (7)

ICO Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

ICO l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Fe

Valencia, 46026, Spain

Location

Related Links

• Blood and Tissue Bank of Catalonia
• Vall d'Hebron Institute of Oncology

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Pere Barba, MD, PhD

  VHIO (Vall d'Hebron Institute of Oncology)

  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: July 9, 2019
• First Posted: July 12, 2019
• Study Start: July 4, 2019
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)