Virus Specific T-Cells for Refractory CMV Infection

Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

Recruiting Phase 2 Interventional Study
Cytomegalovirus Infections Primary Immune Deficiency Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 Month – 79
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
New York Medical College · Other
Who this trial is looking for

This trial is looking for children, adolescents, and young adults with a stubborn CMV infection after stem cell or organ transplant. Participants will receive special T-cells made to fight the CMV virus.

Are You a Good Fit for This Trial?
Rules you out Acute graft-versus-host diseaseCMV retinitis

You may be able to join if

  • I have a refractory CMV infection after a stem cell transplant or organ transplant.
  • I am between 0.1 and 79.99 years old.
  • I have given a signed consent form.
  • I have a related donor with a T-cell response to CMV.
  • I have a performance status greater than 30%.
  • I am a female of childbearing potential with a negative urine pregnancy test.

You may not be able to join if

  • I have had acute graft-versus-host disease worse than grade 2.
  • I am receiving steroids at the time of the T-cell infusion.
  • I have been treated with donor lymphocyte infusion in the last 4 weeks.
  • I have received certain immunosuppressive treatments in the last 30 days.
  • My performance status score is 30% or lower.
  • I have CMV retinitis.
  • I am currently in another experimental clinical trial for CMV infection.
  • I have any serious medical condition that could affect my participation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations
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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 thera…
Contacts

Mitchell S Cairo, MD

914-594-2150

mitchell_cairo@nymc.edu

CONTACT

Lauren Harrison, RN

6172857844

lauren_harrison@nymc.edu

CONTACT