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 outAcute 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 and Karnofsky \> 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test
Donor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s).
a. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMP PepTivator .
AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
AND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.
3 Patient exclusion criteria:
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 lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV infection.
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 to use an effective method of birth control during study treatment.
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
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