Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy

NCT04056533 | Recruiting Phase 2 DMC

• 1 other identifier: INMUNOCELL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.

Conditions

CMV

Keywords

Citomegalovirus; Haploidentical; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• 100-days incidence of CMV infection

  Viral load \>200 copies in 1 sample

  From date of CMV-CTLs infusion to 100 days after transplant

Secondary Outcomes (2)

• 1-year incidence of CMV specific antiviral drug use

  From date of CMV-CTLs infusion to 1 year after transplant

• 1-year incidence of CMV disease

  From date of CMV-CTLs infusion to 1 year after transplant

Other Outcomes (3)

• 1-year incidence of CMV-CTLs adverse events

  From date of CMV-CTLs infusion to 1 year after transplant

• CMV-CTLs persistence

  From date of CMV-CTLs infusion to 2 months after infusion

• Immune reconstitution post-HAPLO

  From date of transplant to day 180 post-transplant

Study Arms (1)

CMV CTLs

EXPERIMENTAL

1x10\^5 CMV-CTLs/kg

Biological: CMV CTLs

Interventions

CMV CTLs BIOLOGICAL

The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.

CMV CTLs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).
• Any source of stem cells (peripheral blood or bone marrow).
• CMV-seropositive donors.
• Negative pregnancy test in women.
• Signed writen informed consent.
• DONORS:
• HLA haploidentical and CMV-seropositve donors.
• Donor must be checked and suitable.
• Signed writen informed consent.
• Donor without active infection evidence at leukapheresis.

You may not qualify if:

• Patients without haploidentical CMV-seropositive donors.
• Patients who are not suitable for follow up visits.
• CMV-CTLs Infusion Criteria:
• Hematopoiesis recovery at least partial (neutrophil counts \>0.5x10\^9/L in at least 3 consecutive samples post-transplant).
• CMV-CTLs NON-Infusion Criteria:
• Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.
• ECOG \> or = 3.
• Organic toxicities grade \> or = 3.
• Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.
• Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.
• Persistent fevers 3 days before infusion.
• Acute Graft Versus Host Disease (GVHD) grade II-IV.
• Relapse or progression after transplant and before infusion day.
• CMV reactivation/infection after transplant and before infusion day.
• Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (1)

Hospital Marques de Valdecilla

Santander, Spain

RECRUITING

Study Officials

• Galo Peralta Fernandez, MD

  Instituto de Investigación Marqués de Valdecilla

  STUDY DIRECTOR

Central Study Contacts

Miriam Sanchez-Escamilla, MD

CONTACT

+34646393234; msanchez@idival.org

Lucía Lavín Alconero, Phd

CONTACT

eclinicos5@idival.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 14, 2019
• Study Start: March 26, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

ES (1)