deltatrials
Recruiting INTERVENTIONAL NCT05101213

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

Sponsor: M.D. Anderson Cancer Center

Updated 15 times since 2021 Last updated: Apr 13, 2026 Started: Jan 6, 2023 Primary completion: Jan 31, 2027 Completion: Jan 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Adenovirus Infection and BK Virus Infection, this trial is actively recruiting participants. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 15 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

PRIMARY OBJECTIVE: I. To assess the feasibility and safety of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines in immunosuppressed cancer patients with viral infections (BKV, JCV, CMV, adenovirus, COVID19). SECONDARY OBJECTIVES: I. To obtain preliminary data about the efficacy of administering genetically engineered glucocorticoid receptor knock out virus specific CTL lines in immunosuppressed cancer patients with viral infections (BKV, JCV, CMV, adenovirus, COVID19). II. To assess the persistence of the administered cells in the patients. III. To obtain data about relapse free survival (RFS) and overall survival (OS). OUTLINE: 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. After completion of study treatment, patients are followed up yearly for 15 years.

PRIMARY OBJECTIVE:

I. To assess the feasibility and safety of administering genetically engineered glucocorticoid receptor knock out virus specific cytotoxic T-lymphocyte (CTL) lines in immunosuppressed cancer patients with viral infections (BKV, JCV, CMV, adenovirus, COVID19).

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering genetically engineered glucocorticoid receptor knock out virus specific CTL lines in immunosuppressed cancer patients with viral infections (BKV, JCV, CMV, adenovirus, COVID19).

II. To assess the persistence of the administered cells in the patients. III. To obtain data about relapse free survival (RFS) and overall survival (OS).

OUTLINE:

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.

After completion of study treatment, patients are followed up yearly for 15 years.

Status Flow

~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshot~Feb 2023 – ~Jul 2023 · 5 months · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~May 2024 · 6 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~May 2025 · 5 months · monthly snapshot~May 2025 – ~Nov 2025 · 6 months · monthly snapshot~Nov 2025 – ~Apr 2026 · 5 months · monthly snapshotApr 17, 2026 – present · 4 months · daily API

Change History

15 versions recorded
  1. Apr 17, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1None

  2. Nov 2025 — Apr 2026 [monthly]

    Recruiting PHASE1

  3. May 2025 — Nov 2025 [monthly]

    Recruiting PHASE1

  4. Dec 2024 — May 2025 [monthly]

    Recruiting PHASE1

  5. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

Show 10 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  2. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  3. Nov 2023 — May 2024 [monthly]

    Recruiting PHASE1

  4. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  5. Jul 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

  6. Feb 2023 — Jul 2023 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  7. Nov 2022 — Feb 2023 [monthly]

    Not Yet Recruiting PHASE1

  8. Sep 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE1

  9. Mar 2022 — Sep 2022 [monthly]

    Not Yet Recruiting PHASE1

  10. Dec 2021 — Mar 2022 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations