Phase 3 study of Posoleucel cell therapy for the treatment of adenovirus infection in children and adults receiving standard of care following transplantation of hematopoietic cells (cells responsible for the production of mature blood cells in bone marrow).

Phase 1

• Conditions: AdV infection in pediatric and adult allo HCT recipients receiving standard of care; MedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-003450-22-ES
• Lead Sponsor: AlloVir, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-22
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female >1 year of age.
2. Has undergone allogeneic (including umbilical cord) cell transplantation =21 days prior to randomization and has demonstrated engraftment with an absolute neutrophil count >500/mm3, AND has one of the following:

a. AdV viremia DNA =10,000 copies/mL at screening, OR
b. Two consecutive and rising AdV viremia DNA results of =1,000 copies/mL at screening, AND
i. has absolute lymphocyte count <180/mm3, OR
ii. has received T cell depletion.

3. Males and females of childbearing potential who engage in heterosexual intercourse must agree to use contraception as detailed in Appendix 5 of this protocol and refrain from donating sperm or eggs for at least 90 days after treatment completion.
4. Willing and able to provide signed informed consent.
5. Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Grade >2 acute GVHD (see Appendix 6 for information on acute GVHD grading and
severity).
2. Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
3. Has either of the following laboratory parameters at screening:
a. Aspartate aminotransferase and alanine aminotransferase serum levels =5 times the
upper limit of normal (ULN), OR
b. Direct bilirubin serum levels =3 times the ULN.

4. Relapse of primary malignancy, or any other active malignancy, except for non-melanoma skin cancer.
5. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated) regardless of attribution ongoing or within 7 days prior to randomization.
6. Uncontrolled viral (other than AdV), bacterial, or fungal infection(s) leading to hemodynamic instability or radiologic or laboratory evidence attributable to worsening disease.
7. Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation.
8. Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
9. Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to randomization.

Other protocol-defined criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified