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RECRUITING Phase 1

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

NCT03594981 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 36 participants
Start Date 2018-01-24
Est. Completion 2025-11
Phase Phase 1

Sponsor

Catherine Bollard

9 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catherine Bollard, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03594981 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03594981?

The interventions under investigation include: CMV/AdV /EBV/BKV specific T cells (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03594981?

This trial is sponsored by Catherine Bollard, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial