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

NCT03425526 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2017-0350NCI-2018-00929
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Immunocompromised

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0

  Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums.

  Up to 1 year

• Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)

  The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients.

  Up to 1 year

Secondary Outcomes (5)

• Overall survival (OS)

  From the start of study treatment up to 1 year

• Relapse-free survival (RFS)

  From the start of study treatment up to 1 year

• Cumulative incidence of adenovirus reactivation after therapy

  Up to 1 year

• Cumulative incidence of graft versus host disease (GVHD)

  Up to 1 year

• Reconstitution of anti-adenovirus immunity

  Up to 1 year

Study Arms (1)

Treatment (allogeneic adenovirus-specific CTLs)

EXPERIMENTAL

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.

Biological: Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Interventions

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes BIOLOGICAL

Given IV

Also known as: Allogeneic Adenovirus-specific CTLs

Treatment (allogeneic adenovirus-specific CTLs)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• David Marin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Marin, MD

CONTACT

713-792-8750; dmarin@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 7, 2018
• Study Start: March 15, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)