Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03594981 · ClinicalTrials.gov registry record · Phase 1
Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
A Phase 1 study of Viral Infection, sponsored by Catherine Bollard.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT03594981 is a Phase 1 study of Viral Infection that is actively recruiting participants, run by Catherine Bollard. The registered enrollment target is 36 participants, below the 226-participant average among 11 other Viral Infection trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03594981, a Phase 1 study of Viral Infection, is actively recruiting participants, sponsored by Catherine Bollard.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.
Conditions Studied
Interventions
- BIOLOGICAL CMV/AdV /EBV/BKV specific T cells
Study Locations (2)
District of Columbia
- Children's National Health System - Washington D.C.
Texas
- M.D. Anderson Cancer Center (MDACC) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2025-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03594981
The ClinicalTrials.gov registry entry for NCT03594981 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 226-participant average among 11 other Viral Infection trials with a reported enrollment target (84% lower). The listed sponsor is Catherine Bollard, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Viral Infection appearing as the primary indexed condition, and to 1 intervention - of which CMV/AdV /EBV/BKV specific T cells is the first listed.
NCT03594981 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Texas.
Frequently Asked Questions
What is clinical trial NCT03594981 about?
NCT03594981 is a clinical study titled "Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis". This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at...
What is the current status of trial NCT03594981?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-01-24. Estimated completion is 2025-11.
What conditions does trial NCT03594981 study?
This clinical trial studies the following conditions: Viral Infection.
What interventions are being tested in trial NCT03594981?
The interventions under investigation include: CMV/AdV /EBV/BKV specific T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03594981?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03594981 being conducted?
This trial has 2 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Viral Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
RECRUITING · Phase 1
-
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
RECRUITING · Phase 1
-
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
RECRUITING · Phase 1
-
Donor-Derived Viral Specific T-cells (VSTs)
RECRUITING · Phase 1
-
Third Party Viral Specific T-cells (VSTs)
RECRUITING · Phase 2
-
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.