Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

NCT ID: NCT03425526

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2027-01-01

Brief Summary

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.

II. To assess the persistence of the administered cells in the patients.

OUTLINE:

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Immunocompromised

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (allogeneic adenovirus-specific CTLs)

Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Intervention Type: BIOLOGICAL

Given IV

Interventions

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

Allogeneic Adenovirus-specific CTLs

Eligibility Criteria

Inclusion Criteria

• Immunocompromised patients.
• English and non-English speaking patients.
• Written informed consent and/or signed assent from patient, parent or guardian.
• Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
• Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
• Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
• Willingness to comply with the study protocol requirements.

Exclusion Criteria

• Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
• Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• Active acute graft versus host disease (GVHD) grade >= 2.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Marin

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Marin, MD

Role: CONTACT

dmarin@mdanderson.org

713-792-8750

Facility Contacts

David Marin

Role: primary

713-792-8750

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2018-00929

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0350

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0350

Identifier Type: -

Identifier Source: org_study_id