RECRUITING

Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity

Conditions

Adenovirus Cytomegalovirus Infections Epstein-Barr Virus Infections Cytokine Capture System Cytomegalovirus Epstein-Barr Virus Hematopoietic Cell Transplant Solid Organ Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.

Official Title

Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity

Quick Facts

Study Start:2025-04-30

Study Completion:2032-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06909110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \<10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered). 2. Active acute GVHD grades II-IV. 3. Active severe chronic GVHD. 4. Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded. 5. Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma). 6. Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion. 7. Patients who are pregnant or lactating. 8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study. 1. Age ≥ 12\* 2. Able to understand and sign the consent/assent to the procedure 3. Partial (2/6 or more) HLA match to the recipient 4. A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors: * Related to the recipient * Apheresis does not need a blood prime before the procedure * Adequate peripheral venous access * Explicit evaluation of the donors' willingness to donate cells, as attested by the research team * Must have understanding that they are helping their ill relative, as attested by the research team * Will gain emotional/psychological benefit from their ability to help and want to donate for a relative, as attested by the research team * Inclusion of minor donors that are not relatives of the recipient will need to be evaluated on a case-by-case basis for the IRB to evaluate the potential benefit to these participants (whether they will receive an emotional and psychological boost from helping the recipient) \*If the only suitable donor is less than 12 years old, a single patient exception to this inclusion criteria will be submitted and approved by the IRB before obtaining the donor's assent and their LAR consent. 1. Donor is pregnant 2. Donor is HIV positive 3. Donor is positive for hepatitis B and/or hepatitis C 4. Deemed to be a high-risk donor based on responses to donor risk questionnaire 5. Deemed high risk due to preexisting medical condition or abnormal lab results

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \<10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).
2. Active acute GVHD grades II-IV.
3. Active severe chronic GVHD.
4. Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.
5. Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).
6. Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.
7. Patients who are pregnant or lactating.
8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
1. Age ≥ 12\*
2. Able to understand and sign the consent/assent to the procedure
3. Partial (2/6 or more) HLA match to the recipient
4. A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors:
* Related to the recipient
* Apheresis does not need a blood prime before the procedure
* Adequate peripheral venous access
* Explicit evaluation of the donors' willingness to donate cells, as attested by the research team
* Must have understanding that they are helping their ill relative, as attested by the research team
* Will gain emotional/psychological benefit from their ability to help and want to donate for a relative, as attested by the research team
* Inclusion of minor donors that are not relatives of the recipient will need to be evaluated on a case-by-case basis for the IRB to evaluate the potential benefit to these participants (whether they will receive an emotional and psychological boost from helping the recipient) \*If the only suitable donor is less than 12 years old, a single patient exception to this inclusion criteria will be submitted and approved by the IRB before obtaining the donor's assent and their LAR consent.
1. Donor is pregnant
2. Donor is HIV positive
3. Donor is positive for hepatitis B and/or hepatitis C
4. Deemed to be a high-risk donor based on responses to donor risk questionnaire
5. Deemed high risk due to preexisting medical condition or abnormal lab results

Contacts and Locations

Principal Investigator

Jessie Alexander, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Jessie Alexander

Palo Alto, California, 94304

United States

Lucile Packard Children's Hospital

Palo Alto, California, 94304

United States

Lucile Packard Children's Hospital

Palo Alto, California, 94305

United States

Collaborators and Investigators

Sponsor: Jessie L. Alexander

Jessie Alexander, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30

Study Completion Date2032-01-01

Study Record Updates

Study Start Date2025-04-30

Study Completion Date2032-01-01

Terms related to this study

Keywords Provided by Researchers

Cytokine Capture System
Adenovirus
Cytomegalovirus
Epstein-Barr Virus
Hematopoietic Cell Transplant
Solid Organ Transplant

Additional Relevant MeSH Terms

Adenovirus
Cytomegalovirus Infections
Epstein-Barr Virus Infections