20 Participants Needed

CMV-Specific CTLs for CMV Infection Post-Transplant

TO
NS
Overseen ByNicole Szuminski
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well special donor immune cells, known as Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes, can combat infections by two viruses, CMV and AdV, which may recur after a transplant. Researchers aim to determine if these donor cells can safely and effectively reduce these infections. Individuals who have undergone a stem cell or organ transplant and are experiencing a CMV or AdV infection, particularly if they cannot tolerate standard antiviral treatments, might be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have received certain T-cell depleting agents or high doses of steroids recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using CMV-specific immune cells is generally safe for patients. One study found that these cells can help manage difficult CMV infections in transplant recipients, suggesting the treatment works without major side effects.

For adenovirus-specific immune cells, the safety information remains less clear. As this trial is in the early stages, researchers are still collecting safety data. Early trials focus on ensuring treatments are safe, so researchers carefully monitor participants for any issues.12345

Why are researchers excited about this trial's treatments?

Unlike standard antiviral medications for cytomegalovirus (CMV) infections post-transplant, which often come with side effects and resistance issues, CMV-specific cytotoxic T lymphocytes (CTLs) offer a more targeted approach. These CTLs are immune cells specifically engineered to hunt down and destroy CMV-infected cells, potentially providing a more precise and effective treatment. Additionally, this approach can be tailored to the individual's immune system, which might lead to fewer side effects and better outcomes. Researchers are excited about this treatment because it harnesses the body's own immune system to fight the infection more naturally and directly.

What evidence suggests that this trial's treatments could be effective for CMV or AdV infection post-transplant?

Research has shown that special immune cells from donors, called CMV-specific CTLs, can effectively treat CMV infections. In this trial, participants will receive these CMV-specific CTLs, which safely locate and destroy the virus in transplant patients. Studies have found that patients treated with these cells often experience a resolution of their CMV infections, offering promise for managing the virus post-transplant. This treatment has been successfully used in adults who have received stem cell transplants, enhancing the body's natural ability to combat viral infections. Another arm of this trial involves participants receiving AdV-specific CTLs, targeting adenovirus infections.12346

Who Is on the Research Team?

SV

Sumithira Vasu, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stem cell or solid organ transplant and are experiencing CMV reactivation despite standard treatment. Participants must be at least 30 days post-transplant, with persistent CMV viremia, and not on high doses of steroids or T-cell depleting agents. A suitable donor must be haploidentical and CMV seropositive.

Inclusion Criteria

Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
Persistent CMV viremia after standard therapy for >= 7 days with or without proven, probable or possible CMV specific organ involvement
Receipt of an allogeneic HCT using bone marrow, peripheral blood, or umbilical cord stem cells
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Exclusion Criteria

Receiving > 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment
Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 28 days of screening for enrollment
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 who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogeneic cytomegalovirus-specific or adenovirus-specific cytotoxic T lymphocytes intravenously. Participants with persistent infection are eligible for a second infusion after 28 days.

4 weeks
1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and viral reactivations.

12 months
Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
Trial Overview The trial is testing the effectiveness of allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (CTLs) from donors in treating CMV infections that recur after a patient has undergone a transplant. The goal is to see if these white blood cells can target and kill the virus.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Treatment (CMV-specific CTLs)Experimental Treatment1 Intervention
Group II: Treatment (AdV-specific CTLs)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sumithira Vasu

Lead Sponsor

Trials
6
Recruited
140+

Citations

specific cytotoxic T lymphocyte therapy resolve CMV ...In conclusion, our results demonstrated that adoptive transfusion of donor-derived CMV-specific CTLs is effective and safe for the treatment of ...
Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes ...This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at ...
Adoptive Therapy with Cytomegalovirus-Specific Cytotoxic ...In this study, we retrospectively compared the efficacy and safety of donor and third-party CMV-specific cytotoxic T lymphocytes (CMV-CTLs) in ...
Virus-Specific T-Cell Therapy for Prophylaxis and Treatment of ...Cytomegalovirus-specific T cells have been used in studies of primarily adult hematopoietic stem cell transplant recipients.
Adoptive therapy with CMV-specific cytotoxic T lymphocytes ...We performed a retrospective analysis of patients receiving CMV-CTLs for treatment of CMV viremia and/or disease after allogeneic transplant ...
Adoptive Therapy with Cytomegalovirus-Specific Cytotoxic ...In this study, we retrospectively compared the efficacy and safety of donor and third-party CMV-specific cytotoxic T lymphocytes (CMV-CTLs) in ...
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