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NCT05101213 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05101213: Recruiting Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT05101213 is a Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101213, a Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL Virus-specific Cytotoxic T-lymphocytes
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
What NCT05101213 shows while recruiting
NCT05101213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (97% lower).
The record links to 7 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Virus-specific Cytotoxic T-lymphocytes is the first listed.
NCT05101213 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05101213 about?
NCT05101213 is a clinical study titled "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". 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...
What is the current status of trial NCT05101213?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-01-06. Estimated completion is 2027-01-31.
What conditions does trial NCT05101213 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, BK Virus Infection, Symptomatic COVID-19 Infection Laboratory-Confirmed, Cytomegaloviral Infection.
What interventions are being tested in trial NCT05101213?
The interventions under investigation include: Virus-specific Cytotoxic T-lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT05101213?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101213 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05101213's enrollment target sits among peer trials
30 146th of 176 higher than 26 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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