What side effects are associated with this type of intervention?

Common treatments for stem cell transplant complications, particularly those involving targeted cellular therapies like Tabelecleucel, include the use of EBV-specific cytotoxic T lymphocytes. The known side effects of these treatments can include cytokine release syndrome (CRS), which manifests as fever, fatigue, and muscle pain. Other potential side effects are graft-versus-host disease (GVHD), which can cause skin rashes, liver dysfunction, and gastrointestinal issues, and infections due to immunosuppression. Additionally, patients may experience hematologic toxicities such as anemia, thrombocytopenia, and neutropenia.

What prior FDA approvals exist?

The FDA has approved several treatments for complications arising from stem cell transplants, particularly those targeting viral infections and immune responses. One notable approval is for the use of allogeneic EBV-specific cytotoxic T lymphocytes (EBV-CTLs) to treat Epstein-Barr virus-associated post-transplant lymphoproliferative disease (PTLD), a serious complication in stem cell transplant patients. This approach, similar to the investigational drug Tabelecleucel, involves the targeted destruction of EBV-infected cells by leveraging the body's immune response. Additionally, other immunotherapies and antiviral agents have been approved to manage infections and immune-related complications in this patient population.

What other types of research exist?

Promising, novel alternatives to Tabelecleucel for patients with stem cell transplant complications in 2024 include CAR T-cell therapies such as axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and idecabtagene vicleucel (ide-cel). These therapies have shown efficacy in treating relapsed/refractory hematologic malignancies and could offer innovative treatment options.

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Virus Therapy

Tabelecleucel for EBV Associated Diseases

Phase 2

Recruiting

Research Sponsored by Atara Biotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have systemic measurable disease and/ or CNS measurable disease

Definitive therapy (eg, allogeneic HCT, gene therapy) for the underlying PID is planned

Must not have

Need for vasopressor or ventilatory support

Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests tabelecleucel, a treatment using special immune cells, in patients with certain diseases related to the Epstein-Barr virus (EBV) who can't use or don't respond to standard treatments. It works by enhancing the immune system's ability to attack virus-infected cells. Tabelecleucel is being tested for recurring or hard-to-treat EBV-related diseases.

Who is the study for?

This trial is for individuals with Epstein-Barr virus-associated diseases, including those who have had stem cell or organ transplants and are experiencing complications. Participants should have measurable disease, be planning definitive therapy, and have a performance status indicating they can perform daily activities. They must not be pregnant, breastfeeding, or require high doses of steroids.

What is being tested?

The study is testing the effectiveness and safety of tabelecleucel in treating various EBV-associated conditions. Tabelecleucel is an investigational treatment aimed at targeting cells infected with the Epstein-Barr virus to help manage these diseases.

What are the potential side effects?

While specific side effects for tabelecleucel are not provided here, similar treatments may cause immune reactions, fatigue, infusion-related symptoms like fever or chills, and potential worsening of underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured by tests in my body or brain.

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I am scheduled for a definitive treatment like a stem cell transplant or gene therapy for my primary immunodeficiency.

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I have been diagnosed with an EBV+ disorder.

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I am 16 or older and can care for myself but not fully active; or I am under 16 and mostly active.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I require medication to maintain my blood pressure or need help to breathe.

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I have a severe reaction from a transplant, known as GvHD.

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My lymphoma is not Burkitt, T-cell (except HLH), NK/T-cell, Hodgkin, or transformed.

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I have had a bone marrow or organ transplant.

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I do not have any serious ongoing infections needing strong medication.

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I am unwilling to follow the study's birth control requirements.

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I am not pregnant or breastfeeding.

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I am currently taking daily steroids higher than 0.5 mg/kg, methotrexate, or undergoing extracorporeal photopheresis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: EBV+ sarcoma, including LMS, or smooth muscle tumorsExperimental Treatment1 Intervention

Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line therapy is inappropriate, including LMS or smooth muscle tumor, will receive IV tabelecleucel.

Group II: EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)Experimental Treatment1 Intervention

Participants with EBV+ PTLD for whom standard first-line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease, will receive IV tabelecleucel.

Group III: EBV+ PID LPDExperimental Treatment1 Intervention

Participants with R/R or newly diagnosed EBV+ PID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

Group IV: EBV+ CNS PTLDExperimental Treatment1 Intervention

Participants with R/R or newly diagnosed EBV+ CNS PTLD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

Group V: EBV+ AID LPDExperimental Treatment1 Intervention

Participants with R/R or newly diagnosed EBV+ AID LPD for whom standard first-line therapy is inappropriate, will receive IV tabelecleucel.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for stem cell transplant complications often involve targeted therapies like Tabelecleucel, which uses EBV-specific cytotoxic T lymphocytes to target and destroy EBV-infected cells. This mechanism is crucial for patients because it directly addresses the viral infections that can cause severe complications post-transplant. By eliminating these infected cells, such treatments help restore immune function and prevent further complications, thereby improving overall patient outcomes.