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: Recruiting Phase 1 study of Viral Infection, sponsored by Catherine Bollard.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The study will determine the optimal dose of intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, Adenovirus and BK virus( BKV) given to patients with or at risk for CMV, EBV, BK virus and adenovirus infection after cord blood transplant. The safety will be assessed by investigational product-related adverse events as per CTCAE v4.03.
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 |
What NCT03594981 shows while recruiting
NCT03594981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 226-participant average among 11 other Viral Infection trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Where NCT03594981's enrollment target sits among peer trials
36 11th of 11 higher than 1 of 11 other Viral Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Viral Infection 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI