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New treatment option for Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Official title Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
ClinicalTrials.gov ID: NCT03665675
What this study is testing
What is Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes?
Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for allogeneic hematopoietic stem cell transplantation recipient.
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
- This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus [CMV] specific cytotoxic T-lymphocytes [CTLs]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific [AdV] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
- Phase 1: an early, usually small safety study
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 85. Healthy volunteers may be eligible.
You may be able to join if
- Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.
- Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
- Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR
- High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR
- Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia...
You likely can't join if
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.
- Receipt of \> 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable...
- Evidence of uncontrolled infection as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to...
- Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings...
See the full eligibility criteria
- Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.
- Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
- Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR
- High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR
- Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
- Cohort B (AdV): Must have documented AdV infection or reactivation, as by:
- Symptomatic subject with any detectable viral load in blood, OR
- Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and/or other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood...
- New, persistent, and/or worsening AdV-related symptoms, signs, and/or markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR
- Asymptomatic with a viral load \> 1000 copies/ml in peripheral blood, OR
- Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
- Karnofsky (age \> 16 years) or Lansky performance score \> 70 (age \< 16)
- Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation
- Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen
- Written informed consent and/or signed assent line from patient, parent or guardian
- DONOR
- Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards
- Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)
- Cohort B: AdV seropositive, defined as detection of serum AdV IgG
- Age 18 or over
- Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for...
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.
- Receipt of \> 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or...
- Evidence of uncontrolled infection as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
- Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients...
- Receipt of donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \> 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression.
- Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.
- Active and uncontrolled relapse of malignancy.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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 year to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. 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.