16 Participants Needed

Donor T Cell Therapy for Adenovirus Infections

DM
Overseen ByDavid Marin, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain high doses of prednisone or have recently received specific treatments like anti-thymocyte globulin or donor lymphocyte infusion.

What data supports the effectiveness of the treatment Donor T Cell Therapy for adenovirus infections?

Research shows that using virus-specific T cells (VSTs) to treat adenovirus infections in patients who have had stem cell transplants is highly effective, with 81% of patients showing improvement and 58% achieving complete recovery. This approach is particularly beneficial for those with weakened immune systems, as traditional antiviral drugs often have limited success and can cause significant side effects.12345

Is Donor T Cell Therapy for Adenovirus Infections safe for humans?

Research indicates that Donor T Cell Therapy, also known as Virus-Specific T Cells (VSTs), is generally safe for treating adenovirus infections in humans, especially in those with weakened immune systems. Studies have shown that this therapy can effectively manage viral infections without significant acute toxicity or increased risk of graft-versus-host disease (a condition where donor cells attack the recipient's body).15678

How is Donor T Cell Therapy different from other treatments for adenovirus infections?

Donor T Cell Therapy is unique because it uses virus-specific T cells from a donor to help the patient's immune system fight adenovirus infections, especially in those with weakened immune systems after stem cell transplants. Unlike traditional antiviral drugs, which can have limited effectiveness and significant side effects, this therapy directly boosts the body's ability to target and eliminate the virus.12357

What is the purpose of this trial?

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Research Team

David Marin | MD Anderson Cancer Center

David Marin

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for immunocompromised patients with blood cancers and asymptomatic adenovirus viremia, or those showing probable or definitive signs of the disease. Participants must consent, not be pregnant, agree to use contraception if applicable, and cannot have certain uncontrolled infections or recent treatments that suppress the immune system.

Inclusion Criteria

I am not pregnant and willing to use birth control during the study.
I have a virus in my blood but feel fine, confirmed by tests.
I have been diagnosed with an adenoviral disease.
See 2 more

Exclusion Criteria

I am not currently taking high doses of prednisone, nor have I recently received specific immune treatments.
I have no worsening infections and am on treatment if I have any.
I have a severe reaction from a transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive allogeneic adenovirus-specific cytotoxic T lymphocytes intravenously over 30 minutes. Additional infusions may be given at the discretion of the investigator.

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety, efficacy, and persistence of the administered cells after treatment

12 months
Regular visits as per study protocol

Treatment Details

Interventions

  • Donor T Cell Therapy
Trial Overview The study tests donor T cell therapy using allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) in patients with weakened immune systems due to blood cancers. These CTLs are grown from donated cells aimed at fighting off adenovirus infections.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (allogeneic adenovirus-specific CTLs)Experimental Treatment1 Intervention
Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

Donor T Cell Therapy is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Allogeneic Adenovirus-Specific Cytotoxic T Lymphocytes for:
  • Adenovirus-related disease in immunocompromised patients
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Donor-Derived Adenovirus-Specific CTLs for:
  • Refractory adenovirus infections post allogeneic hematopoietic stem cell transplantation

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a phase 1/2 clinical trial involving 30 pediatric patients, ex vivo-generated virus-specific T cells (VSTs) demonstrated a high clinical response rate of 81% for treating adenoviral infections after hematopoietic stem cell transplantation, with 58% achieving complete response.
The study indicates that VSTs, whether derived from the stem cell donor or healthy third-party donors, are a safe and effective alternative to traditional antiviral treatments, which often have limited efficacy and significant side effects.
Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted.Rubinstein, JD., Zhu, X., Leemhuis, T., et al.[2022]
A clinical-grade method was developed to isolate and expand adenovirus-specific T cells from donors, yielding an average of 3.4 million specific T lymphocytes from peripheral blood or leukapheresis products, which is crucial for restoring immunity in patients with lymphopenia after stem cell transplantation.
The generated T cell lines demonstrated effective responses against adenovirus-infected cells and showed reduced alloreactive proliferation, indicating their potential for safe and effective adoptive immunotherapy in combating ADV infections.
Isolation and expansion of human adenovirus-specific CD4+ and CD8+ T cells according to IFN-gamma secretion for adjuvant immunotherapy.Feuchtinger, T., Lang, P., Hamprecht, K., et al.[2019]
Adenoviruses are common but usually not dangerous for healthy individuals, while they can cause serious illness in immunocompromised patients, highlighting the need for effective treatments in these vulnerable groups.
The study suggests that using in vitro expanded virus-specific cytotoxic T lymphocytes (CTLs) could be a promising approach for treating or preventing adenovirus infections in immunosuppressed patients, as these T cells play a crucial role in controlling the virus in the body.
T-cell immunotherapy for adenoviral infections of stem-cell transplant recipients.Leen, AM., Myers, GD., Bollard, CM., et al.[2007]

References

Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. [2022]
Isolation and expansion of human adenovirus-specific CD4+ and CD8+ T cells according to IFN-gamma secretion for adjuvant immunotherapy. [2019]
T-cell immunotherapy for adenoviral infections of stem-cell transplant recipients. [2007]
Detection of adenovirus-specific T cells in children with adenovirus infection after allogeneic stem cell transplantation. [2008]
T cells for viral infections after allogeneic hematopoietic stem cell transplant. [2021]
Adoptive T-cell immunotherapy from third-party donors: characterization of donors and set up of a T-cell donor registry. [2022]
Curative or pre-emptive adenovirus-specific T cell transfer from matched unrelated or third party haploidentical donors after HSCT, including UCB transplantations: a successful phase I/II multicenter clinical trial. [2018]
Identification of the best-suited donor for generating virus-specific T cells. [2020]
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