Is NCT05664126 recruiting in Memphis, TN?

Yes, NCT05664126 is currently recruiting participants at its Memphis, TN location. This cytomegalovirus clinical trial is actively enrolling qualified participants.

How do I join the cytomegalovirus clinical trial in Memphis?

To join this clinical trial in Memphis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Memphis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cytomegalovirus Clinical Trial in Memphis, TN

About This Cytomegalovirus Study in Memphis

The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection. Primary objective To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion. When the initial viral load is \<1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection. Secondary objectives * Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT. * Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion. * Assess the persistence of response for 6 months post-infusion.

Sponsor: St. Jude Children's Research Hospital

Who Can Participate

Inclusion Criteria

for Patients:

Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.

Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.

Patients have no suspected or confirmed GVHD.

Availability of haploidentical donor for isolation of virus-specific T-cells.

Have not received a Donor Lymphocyte Infusion in the past 4 weeks.

Female patients of childbearing age must have a negative pregnancy test.

Subject, parent, or guardian are capable of giving signed informed consent.

Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%.

Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.

Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL/min/1.73m2 (may use estimated GFR that is auto calculated in the EHR).

Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.

Patients must have FVC \>50% predicted or able to maintain pulse oximetry saturation \> 92% on room air.

Gut diarrhea \<1 liter/day (adults) or \<20mL/kg/day (children) or if unable to quantify, then occurrence of 4 stools per day above baseline.

Patients must have engrafted with an ANC \>500 cells/mm3 for 3 consecutive days. Inclusion criteria for donors

Age ≥18 years.

At least single haplotype matched (≥3/6) family member.

Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).

HIV negative.

For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.

Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR.

Identified recipient with CMV and/or ADV reactivation post-HCT.

Exclusion Criteria

for Patients:

Active GVHD.

Inability to provide consent.

Need for vasopressor or ventilatory support Patients receiving steroids \>0.5 mg/kg prednisone equivalent at the time of VST infusion

Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.

Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.

Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Memphis?

Yes, this clinical trial (NCT05664126) has an active research site in Memphis, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cytomegalovirus Treatment Options in Memphis, TN

If you're searching for cytomegalovirus treatment options in Memphis, TN, this clinical trial (NCT05664126) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Memphis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cytomegalovirus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cytomegalovirus clinical trials near you to find additional studies recruiting in your area.

Cytomegalovirus Clinical Trial in Memphis, TN

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