Using virus-specific T-cells to treat CMV infections in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to administer cytotoxic T-lymphocytes (CTLs) specifically targeting cytomegalovirus (CMV) to children, adolescents, and young adults suffering from refractory CMV infections following allogeneic hematopoietic stem cell transplantation or solid organ transplantation. The CTLs are manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System and are intended for patients who have not responded to standard antiviral therapies. The study will evaluate the safety and efficacy of this innovative treatment approach in a vulnerable patient population with primary immune deficiencies.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• New York Medical College
  Valhalla, New York, United States Recruiting

Study contacts

• Principal investigator: Mitchell S Cairo, MD — New York Medical College
• Study coordinator: Mitchell S Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 914-594-2150

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CMV-specific T cells after CMV reactivation in adults after HSCT

  This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07688759

• Biomarkers linked to congenital CMV using newborn blood spots

  Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 1 other locations · NCT07635368

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

• Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant

  This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.

  Recruiting Phase 3 New York Medical College · Valhalla, New York and 1 other locations · NCT07225972

• CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants

  Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.

  Recruiting University of Pisa · Trieste · NCT07013370

• R-MVST cell therapy for viral infections in children and young adults

  This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.

  Recruiting Phase 1 Columbia University · New York, New York · NCT06926894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.