Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

NCT05101213 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2020-0332NCI-2021-09078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.

Conditions

Adenovirus Infection; BK Virus Infection; Cytomegaloviral Infection; Hematopoietic and Lymphoid Cell Neoplasm; JC Virus Infection; Malignant Solid Neoplasm; Symptomatic COVID-19 Infection Laboratory-Confirmed

Outcome Measures

Primary Outcomes (1)

• Feasibility of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines, as indicated by Overall Survival

  through study completion, an average of 1 year

Study Arms (1)

Treatment for viral infections (virus-specific CTLs)

EXPERIMENTAL

Patients receive virus-specific CTLs intravenously (IV) over 30 minutes. Patients with partial response, stable disease, or progressive disease may receive up to 8 additional infusions of virus-specific CTL at least 2 weeks between each infusion.

Biological: Virus-specific Cytotoxic T-lymphocytes

Interventions

Virus-specific Cytotoxic T-lymphocytes BIOLOGICAL

Given IV

Also known as: Virus-specific CTLs

Treatment for viral infections (virus-specific CTLs)

Eligibility Criteria

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

You may qualify if:

• Patients \> or = 18 years of age or older.
• For BKV, ADV or CMV infections: Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells or single or double umbilical cord blood. For JC virus and COVID19 infection: no prior hematopoietic stem cell transplantation (HSCT) is required.
• For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms.
• For ADV infection, patients need to have PCR positive for ADV in peripheral blood AND/OR patients need to fit criteria of probable or definitive adenovirus organ disease.
• For CMV infection, patients need to have PCR positive for CMV in peripheral blood AND/OR patients need to fit criteria of probable or definitive CMV disease.
• For JCV, patients need to have documented JC viral encephalitis or JC end-organ disease.
• For COVID-19 infection, patients need to have COVID-19 related pneumonia/acute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage \[BAL\], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS.
• Written informed consent from patient or designated power of attorney.
• Subjects are also are required to consent to PA17-0483 for long term follow up per the guidelines set forth by the Food and Drug Administrations' (FDA's) Biologic Response Modifiers Advisory Committee (BRMAC).
• Negative pregnancy blood 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 at least two forms of birth control during the study and for at least 6 months after stopping treatment. Acceptable forms of birth control include intrauterine device (IUD), hormonal methods (birth control pills, injections, and implants), condoms, diaphragms, tubal ligation, or vasectomy.

You may not qualify if:

• Patients 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 (excluding human immunodeficiency virus \[HIV\]/acquired immunodeficiency syndrome \[AIDS\]). For bacterial infections, patients must be receiving definitive therapy and have signs of improving infection prior to enrollment as determined by the principal investigator (PI). For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have signs of improving infection prior to enrollment as determined by the PI.
• Patients with active steroid refractory graft versus host disease (GVHD).
• Patients on immunosuppressive therapy other than tacrolimus, sirolimus or steroids
• Active and uncontrolled relapse of malignancy. Patients with controlled malignancy on maintenance therapy would be eligible for the study.

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

• M D Anderson Cancer Center

MeSH Terms

Conditions

Adenoviridae Infections; Cytomegalovirus Infections; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Herpesviridae Infections; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• May Daher, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

May Daher, MD

CONTACT

(713) 745-3456; mdaher@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: August 30, 2021
• First Posted: November 1, 2021
• Study Start: January 6, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)