A Phase 1 interventional study of CMV-specific T-cells in CMV Infection, Cytomegalovirus Infections and CMV Viremia, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment
Among 178 studies in Cytomegalovirus Infections with a site in United States — 15 open to participants now, 21 under way, 2 of them phase 3. Cytomegalovirus Infections · United States.
Among the 178 studies in Cytomegalovirus Infections with a site in United States, this one is the 135th largest by enrollment of the 139 interventional ones that give a count, is one of 6 that started in 2020, is one of 41 in phase 1, and was the 137th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
Browse Cytomegalovirus Infections studies →15 of the 178 studies in Cytomegalovirus Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Amivas Inc. · Sites in United States, Australia
Ages 18+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
University of Wisconsin, Madison · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: 1 Month and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
178 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 47 · Phase 3 25 · Phase 4 13
First in 1996; this study’s year is marked. 6 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 64 across 240 interventional studies indexed under Cytomegalovirus Infections.
Median enrollment 61 across the 139 interventional studies, 153 across the 25 observational. Of the 151 that completed or were terminated, 44 (29%) have results posted.
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60 of 178 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 3 studies filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
8 of the studies in Cytomegalovirus Infections with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06407232Phase 3University of Wisconsin, MadisonLetermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients | 2027-08 |
| NCT03354728City of Hope Medical CenterMulti-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant | 2026-12-11 |
| NCT06066957University of PennsylvaniaOpen Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients | 2026-12-15 |
| NCT03266640New York Medical CollegeVirus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) | 2026-12-31 |
| NCT05234723IRCCS Azienda Ospedaliero-Universitaria di BolognaGanciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients | 2027-02-28 |
Add all 8 to your calendar (.ics) → With an account.
Among the 178 studies in Cytomegalovirus Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections.
The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
Participants will be followed for one year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult or pediatric patient suffering from CMV reactivation/infections following or due to other states (e.g.; primary immunodeficiency, cytotoxic therapy).
Patients must have ONE OF THE FOLLOWING CRITERIA:
Exclusion Criteria:
Donor Eligibility:
The original donor will be the first choice as source of T cells. If the original donor is not available for donation (such as NMDP donor, cord blood unit, or related donor not available) of peripheral mononuclear cells or does not meet all donor eligibility criteria (including donor selection criteria based on University of Wisconsin - Madison Standard Operating Procedures for the selection of allogeneic donors), alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 3/6 HLA loci).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection.
Biological: CMV-specific T-cells
Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells
Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer
The feasibility of this intervention will in part be accomplished by measuring the number of dropped out participants before T-Cell Transfer.
Time frame: up to 21 days from enrollement
Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST
The feasibility of this intervention will in part be accomplished by measuring the amount of time from participant enrollment to administration of Cytomegalovirus-Viral Specific T-Cells (CMV-VST).
Time frame: up to 21 days from enrollment
Feasibility: Successful production of CMV-VST from donors
The feasibility of this intervention will be assessed by quantifying the number of successful productions of Cytomegalovirus-Viral Specific T-Cells (CMV-VST) on an intent to treat basis.
Time frame: up to 21 weeks from enrollment
Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion
Incidence assessed by monitoring vital signs and specific adverse events
Time frame: up to 4 hours after CMV-VST infusion
Safety: Number of Subjects who experience newly occurring acute GVHD grade 1
Incidence of subjects who experience newly occurring acute GVHD grade 1
Time frame: up to 12 weeks from CMV-VST infusion
Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD
Incidence of newly occurring acute GVHD grade ≥ 2 or increase in grade of pre-existing acute GVHD
Time frame: up to 12 weeks from CMV-VST infusion
Safety: Number of subjects experiencing chronic GVHD
Incidence of chronic GVHD
Time frame: up to 12 weeks from CMV-VST infusion
The number of severe infusion-related adverse events or severe non-hematological adverse events
Incidence of infusion-related adverse events ≥ grade 3 and non-hematological adverse events ≥ grade 4 after CMV-VST, which are not due to pre-existing infection or original malignancy or pre-existing condition
Time frame: up to 28 days from CMV-VST infusion
Safety: Time to Occurrence of GVHD
Time to occurrence of acute GVHD of any grade or to occurrence of chronic GVHD will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute or chronic GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade, acute or chronic. Overall cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Percentage of Participants with a ≥1 log decrease in CMV viral load
Evaluation of efficacy will in part be measured by percentage of participants with a ≥1 log decrease in CMV viral load at Week 12.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Time to ≥1 log change in viral load
Evaluation of efficacy will in part be measured by time to ≥1 log change in viral load in days.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Number of Participants with CMV Clearance
Evaluation of efficacy will in part be measured by the number of patients with CMV clearance, defined as negative Polymerase Chain Reaction (PCR) from Day 7 to Week 12 after T-cell transfer.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Time to CMV Clearance
Evaluation of efficacy will in part be measured by the time to CMV clearance (defined as negative PCR) from Day 0 to first day of two subsequent negative CMV PCR studies.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms
Evaluation of efficacy will in part be measured by the number of participants with reduction or clearance of clinical symptoms of underlying CMV infection from Day 7 to Week 12 after T-cell transfer as compared to Day 0.
Time frame: up to 12 weeks from CMV-VST infusion
Efficacy: Number of CMV Reactivations Following Initial Viral Clearance
Evaluation of efficacy will in part be measured by the number of CMV reactivations following initial viral clearance until Week 52.
Time frame: up to 52 weeks from CMV-VST infusion
Efficacy: Overall Survival
Evaluation of efficacy will in part be measured by the overall survival. Overall survival rate (OS): time from T-cell transfer (Day 0) to death or last follow-up throughout the study from Day 1 to Week 52.
Time frame: up to 52 weeks
Plan to share: No
Ran from Feb 2020 to primary completion in May 2023, 39 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison →