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NCT04364178 · ClinicalTrials.gov registry record · Phase 1
Viral Specific T-Lymphocytes to Treat Adenovirus or CMV
A Phase 1 study of Cytomegalovirus Infections and Adenovirus, sponsored by Jessie L. Alexander.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT04364178: Active Phase 1 study of Cytomegalovirus Infections and Adenovirus, sponsored by Jessie L. Alexander.
NCT04364178 is a Phase 1 study of Cytomegalovirus Infections and Adenovirus that is active but no longer recruiting, run by Jessie L. Alexander. The registered enrollment target is 25 participants, below the 202-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04364178, a Phase 1 study of Cytomegalovirus Infections and Adenovirus, is active but no longer recruiting, sponsored by Jessie L. Alexander.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus and CMV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus and CMV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus or CMV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Primary Outcome
Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Conditions Studied
Interventions
- BIOLOGICAL Adenovirus Specific T- Lymphocytes
- BIOLOGICAL Cytomegalovirus Specific T-Lymphocytes
Study Locations (2)
California
- Jessie Alexander - Palo Alto
- Lucile Packard Children's Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 1 |
What the registry record for NCT04364178 still lists
NCT04364178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 202-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 2 interventions - of which Adenovirus Specific T- Lymphocytes is the first listed.
NCT04364178 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04364178 about?
NCT04364178 is a clinical study titled "Viral Specific T-Lymphocytes to Treat Adenovirus or CMV". The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus and CMV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. ...
What is the current status of trial NCT04364178?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-08-12. Estimated completion is 2032-01-01.
What conditions does trial NCT04364178 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections, Adenovirus.
What interventions are being tested in trial NCT04364178?
The interventions under investigation include: Adenovirus Specific T- Lymphocytes (BIOLOGICAL), Cytomegalovirus Specific T-Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT04364178?
This trial is sponsored by Jessie L. Alexander, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04364178 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04364178's enrollment target sits among peer trials
25 18th of 24 higher than 5 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
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