20 Participants Needed

T Cell Therapy for Cytomegalovirus

MH
Overseen ByMari H Dallas, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with certain conditions requiring high doses of steroids or recent treatment with specific therapies are excluded, which might imply some restrictions. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment T Cell Therapy for Cytomegalovirus?

Research shows that using CMV-specific T cells can help rebuild the body's defense against the virus after stem cell transplants, reducing the need for antiviral drugs and preventing further virus reactivation in most patients. This approach has been effective and safe, even when using T cells from partially matched donors.12345

Is T Cell Therapy for Cytomegalovirus safe for humans?

The safety of T Cell Therapy for Cytomegalovirus is not directly addressed in the provided research articles, which focus on CAR-T cell therapy for other conditions. However, CAR-T cell therapy can have serious side effects, including infections and immune-related issues, which may be relevant to consider.678910

How is the T cell therapy for cytomegalovirus different from other treatments?

This treatment uses specially engineered T cells to target and fight the cytomegalovirus, offering a personalized approach that can restore long-lasting immunity without the need for antiviral drugs. Unlike traditional treatments, it involves the rapid generation and expansion of virus-specific T cells from the patient's own blood, making it a unique and effective option for patients who have undergone stem cell transplants.1231112

What is the purpose of this trial?

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

Research Team

MH

Mari H Dallas, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients who've had a bone marrow transplant and are over 30 days post-transplant, with CMV infections not improving after antiviral therapy or those experiencing side effects from such treatments. Participants need to be able to consent and use contraception if applicable. Excluded are pregnant/breastfeeding women, recent recipients of certain immune therapies, those with other viral infections or active severe graft vs. host disease.

Inclusion Criteria

My viral load hasn't improved after 2 weeks of antiviral treatment, or I've had new or ongoing symptoms, or I can't tolerate the medication, or my CMV infection has come back twice.
I am capable of limited self-care and spend more than half of my waking hours out of bed.
I agree to use birth control during the study.
See 3 more

Exclusion Criteria

I am currently experiencing severe graft vs. host disease or need high doses of steroids.
I have a viral infection that is not CMV.
I have not received virus-specific T cell therapy in the last 6 weeks.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time infusion of CMV-specific adoptive T-cells

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Regular monitoring visits

Extended Follow-up

Participants are monitored for adverse events and response rate up to 100 days after transplant

Up to 100 days

Treatment Details

Interventions

  • CMV specific adoptive t-cells
Trial Overview The study tests the feasibility of using donor-derived T-cells that target cytomegalovirus (CMV) in patients who have received a bone marrow transplant. This cell-based immunotherapy aims to bolster the patient's immune response against CMV infection.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CMV specific adoptive t-cellsExperimental Treatment1 Intervention
This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.

CMV specific adoptive t-cells is already approved in United States, European Union, China for the following indications:

🇺🇸
Approved in United States as CMV-specific T-cells for:
  • Investigational for CMV infections post-transplant
🇪🇺
Approved in European Union as CMV-specific T-cells for:
  • Investigational for CMV infections post-transplant
🇨🇳
Approved in China as CMV-specific T-cells for:
  • Investigational for CMV infections post-transplant

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mari Dallas

Lead Sponsor

Trials
2
Recruited
40+

Findings from Research

In a study involving 16 patients, treatment with polyclonal CMV-specific T-cell lines led to significant in-vivo expansion of these immune cells, effectively reconstituting viral immunity against CMV infection after transplantation.
The use of these T-cell lines was shown to be effective, as eight patients did not require antiviral drugs, and only two experienced subsequent reactivation of the virus, highlighting the potential of this therapy in clinical settings.
Adoptive cellular therapy for early cytomegalovirus infection after allogeneic stem-cell transplantation with virus-specific T-cell lines.Peggs, KS., Verfuerth, S., Pizzey, A., et al.[2023]
CMV infection is a major risk after allogeneic stem cell transplantation, but reconstituting CMV-specific T cell responses can help protect patients from developing CMV disease.
Two strategies to enhance T cell immunity against CMV include transferring selected CMV-specific T cells directly from the donor to the patient and expanding these T cells in vitro using antigen presenting cells, both of which aim to improve patient outcomes.
CMV-specific T cell therapy.Einsele, H., Kapp, M., Grigoleit, GU.[2007]
A novel method using synthetic CpG oligodeoxynucleotides and modified vaccinia Ankara (MVA) to expand CMV-specific CD4(+) and CD8(+) T cells resulted in a 30-fold increase in T cell populations within 10 days, demonstrating high efficacy for potential therapeutic use.
The expanded T cells showed minimal alloreactivity and strong cytotoxic activity against CMV, making this approach promising for managing CMV viremia in patients undergoing hematopoietic stem cell transplantation.
In vitro expansion of polyclonal T-cell subsets for adoptive immunotherapy by recombinant modified vaccinia Ankara.La Rosa, C., Wang, Z., Lacey, SF., et al.[2008]

References

Adoptive cellular therapy for early cytomegalovirus infection after allogeneic stem-cell transplantation with virus-specific T-cell lines. [2023]
CMV-specific T cell therapy. [2007]
In vitro expansion of polyclonal T-cell subsets for adoptive immunotherapy by recombinant modified vaccinia Ankara. [2008]
Adoptive therapy with CMV-specific cytotoxic T lymphocytes depends on baseline CD4+ immunity to mediate durable responses. [2021]
Clinical-scale isolation of 'minimally manipulated' cytomegalovirus-specific donor lymphocytes for the treatment of refractory cytomegalovirus disease. [2014]
[Management of adverse events of CAR-T therapy]. [2023]
Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. I: Structuring centers for the multidisciplinary clinical administration and management of CAR-T cell therapy patients. [2021]
Case Report: Fatal cytomegalovirus pneumonia after CAR-T cell therapy in the long-term follow-up. [2023]
Cytomegalovirus infection in chimeric antigen receptor T-cell recipients. [2023]
Toxicities following CAR-T therapy for hematological malignancies. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Rapid generation of combined CMV-specific CD4+ and CD8+ T-cell lines for adoptive transfer into recipients of allogeneic stem cell transplants. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Definition of human cytomegalovirus-specific target antigens recognized by cytotoxic T cells generated in vitro by using an autologous lymphocyte system. [2006]
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