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New treatment option for Cytomegalovirus Infections
Official title Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
ClinicalTrials.gov ID: NCT03266640
What this study is testing
What is viral specific cytotoxic t-lymphocytes?
viral specific cytotoxic t-lymphocytes is an investigational medicine, being studied as a potential treatment for cytomegalovirus infections.
Also referred to as CMV CTLs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 79
You may be able to join if
- 1\. Patients with refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either
- Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
- ANC \< 500/mm2 secondary to ganciclovir
- 2 renal toxicity with foscarnet And/or
You likely can't join if
- A patient meeting any of the following criteria is not eligible for the present study:
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of CMV CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone...
- Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient...
- Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies CMV retinitis, meningitis, encephalitis, and/or cerebritis
See the full eligibility criteria
- 1\. Patients with refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either
- Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
- ANC \< 500/mm2 secondary to ganciclovir
- 2 renal toxicity with foscarnet And/or
- known resistance to ganciclovir and/or foscarnet Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. Performance Status \> 30% (Lansky \ 16 yrs) Age: 0.1...
- A patient meeting any of the following criteria is not eligible for the present study:
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of CMV CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor...
- Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient of childbearing age who is pregnant or breast-feeding or not willing...
- Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies CMV retinitis, meningitis, encephalitis, and/or cerebritis
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Valhalla, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Valhalla, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.