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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits
• Collaborators: Hospital Universitario La Fe; Vall d'Hebron Institute of Oncology

Criteria

Inclusion Criteria:

1. 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

2. 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

1. Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment

2. 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.

3. 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

4. Documented genetic mutations associated with ganciclovir or foscarnet resistance

3. ≥ 1 year of age

4. Estimated life expectancy > 30 days

5. Signature of the informed consent form

Exclusion Criteria:

1. Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate

2. Corticosteroid ≥ 0.5mg/kg regardless the indication

3. Disease relapse at the time of infection or at any time after the Allogeneic transplant.

4. Severe renal disease (creatinine > 3gr/dL)

5. Severe hepatic disease (bilirubin >3mg/dL or aspartate aminotransferase (AST) >500 U/L) except if it is secondary to the viral infection.

6. Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.

7. 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

8. Known hypersensitivity to murine proteins or iron dextran.

9. Positive serology to human immunodeficiency virus (HIV), hepatitis B virus (HBV) (HBsAg, HBcAc), hepatitis C virus (HCV) and/or syphilis

10. Pregnant, lactating or women without adequate contraception

11. Participation in a clinical trial with investigational medicinal products the last 30 days