Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT

NCT05075837 | Not Yet Recruiting Phase 1

• 1 other identifier: IGianninaGaslini
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).

Conditions

Viral Infection After HSCT

Keywords

CMV; adenovirus; EBV; adoptive T cell therapy; allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Adverse events

  To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE)

  from day +1 of infusion until day +56

Secondary Outcomes (4)

• Specific cell viral immunity

  from day +1 of infusion until day +56

• Variation of viremia

  from day +1 of infusion until day +56

• Organ damage

  from day +1 of infusion until day +56

• Overall survival

  from day +56 to 12 months

Study Arms (1)

Virus-specific T cells for the treatment of active viral infections following allogeneic HSCT.

EXPERIMENTAL

Virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT)

Biological: Virus -specific T cells

Interventions

Virus -specific T cells BIOLOGICAL

The product is obtained by leukapheresis of a family donor responsive to the virus: consists of virus- specific T lymphocytes (both CD4+ and CD8+) resuspended in PBS / EDTA buffer plus 0.5% Albumin Human. The productive process lasts two consecutive days and includes two phases: a brief activation with specific viral peptide followed by immunomagnetic separation using the CliniMACS® CCS (IFNγ) capture system which allows a fast and automated separation of IFNγ secreting lymphocytes

Virus-specific T cells for the treatment of active viral infections following allogeneic HSCT.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Allogeneic transplant with any cells source and conditioning regimen
• Age between 0-21 years
• Viral infection/reactivation (CMV, EBV, ADV)
• Resistance of viral infections to treatments
• Absence of concomitant severe uncontrolled infections
• Life expectancy exceeding 30 days
• Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
• Absence of acute kidney damage (creatinine value\> 3 times the value normal with respect to age) not related to viral infection;
• Absence of severe acute liver injury (direct bilirubin\> 3mg / dl or glutamic-oxaloacetic transaminase -SGOT\> 500 UI/L) not related to viral infection;
• Presence of informed consent to the treatment of the patient / parent /legal guardian.

You may not qualify if:

• Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
• Patient with severe renal and/or hepatic impairment as specified above
• Primary or secondary graft failure
• Relapse of malignant underlying disease

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Maura Faraci, MD

  Istituto G. Gaslini

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maura Faraci, MD

CONTACT

01056362405; maurafaraci@gaslini.org

Stefano Giardino, MD

CONTACT

01056362405; stefanogiardino@gaslini.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Phase I, open-label, single-arm, non-randomized study, monocentric.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 13, 2021
• Study Start: February 27, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share