Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy

Who is this study for? Adultss who received an alogeneic stem cell transplantation from haploidentical donors
What treatments are being studied? CMV CTLs
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Marques de Valdecilla
RECRUITING
Santander
Contact Information
Primary
Miriam Sanchez-Escamilla, MD
msanchez@idival.org
+34646393234
Backup
Lucía Lavín Alconero, Phd
eclinicos5@idival.org
Time Frame
Start Date: 2022-03-26
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 15
Treatments
Experimental: CMV CTLs
1x10\^5 CMV-CTLs/kg
Sponsors
Leads: Instituto de Investigación Marqués de Valdecilla

This content was sourced from clinicaltrials.gov

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