Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can cord blood t cells be trained to stop viral infections after transplant?

NCT ID NCT03594981

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial is testing whether specially grown T cells from cord blood can help prevent or treat infections caused by common viruses (CMV, EBV, BKV, and adenovirus) in people who have had a cord blood transplant. The study aims to find the safest and most effective dose of these virus-specific T cells. Participants receive an intravenous infusion of the cells, and researchers monitor for side effects and how long the cells survive in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV, and adenovirus
What this could lead to
If successful, this could offer a way to prevent or treat serious viral infections after cord blood transplants, potentially improving survival and reducing complications.
What could go wrong
This is an early-phase trial with a small number of participants, so the optimal dose and safety are still being determined. There is a risk of side effects like graft-versus-host disease or the cells not working as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

2 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria at the Time of Procurement * Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant. * Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either: 1. be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below. OR 2. be cryopreserved with a cell dose that totals \> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to give at day 30 or beyond and the remaining 80% will be used for the primary transplant. 3. For recipients of double CBT, if possible both CB units should be cryopreserved in two fractions and T-cells will be made from both units if possible. Inclusion Criteria at the Time of CTL Infusion * Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral/BKV and/or EBV infection or reactivation. * Lansky/Karnofsky scores ≥60 * Absolute neutrophil count (ANC) greater than 500/u * No evidence of GVHD \> Grade II at time of enrollment * Life expectancy \> 30 days * Absence of severe renal disease (Creatinine \< 3x normal for age) * Absence of severe hepatic disease. Direct bilirubin must be \< 3 mg/dl and AST \< 5x upper limit of normal * Patient must be at least 30 days post transplant to be eligible to receive CTL * Written informed consent and/or signed assent line from patient, parent or guardian Exclusion Criteria: Exclusion Criteria at the Time of Procurement * Pregnant or lactating * Patients with active central nervous system disease * Patients with Karnofsky performance status \<70% * Patients with grade 3 or 4 or primary myelofibrosis * Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion * Pregnant or lactating * Patient on Fi02 of \>60% * Unable to wean steroids to ≤0.5 mg/kg/day prednisone or equivalent * Patients with Grade 3 hyperbilirubinemia * Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia and/or BK viruria/viremia). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. * Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease * Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Adenovirus infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Children's National Health System

    Washington D.C., District of Columbia, 20010, United States

  • M.D. Anderson Cancer Center (MDACC)

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.