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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test a new treatment for diseases caused by the Epstein-Barr virus.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
For EBV+ PID LPD cohort: Number of participants who reach definitive therapy (ie, allogeneic HCT) for the underlying disease
For EBV+ PID LPD cohort: Time to definitive therapy
+4 moreTrial 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.
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.
Find a Location
Who is running the clinical trial?
Atara BiotherapeuticsLead Sponsor
13 Previous Clinical Trials
541 Total Patients Enrolled
3 Trials studying Stem Cell Transplant Complications
74 Patients Enrolled for Stem Cell Transplant Complications
Dr. Faith Galderisi, DOStudy DirectorAtara Biotherapeutics
Justin Wahlstrom, MDStudy DirectorAtara Biotherapeutics
2 Previous Clinical Trials
252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by tests in my body or brain.I require medication to maintain my blood pressure or need help to breathe.I have a severe reaction from a transplant, known as GvHD.I haven't had certain cell therapies or treatments that affect immune cells within the last 8 weeks.My lymphoma is not Burkitt, T-cell (except HLH), NK/T-cell, Hodgkin, or transformed.I am scheduled for a definitive treatment like a stem cell transplant or gene therapy for my primary immunodeficiency.I have had a bone marrow or organ transplant.I haven't taken any experimental drugs or cancer treatments recently.My organs work well, unless the issue is caused by my EBV-related disease.I have followed the required waiting period after my last treatment before joining.I do not have any serious ongoing infections needing strong medication.I am unwilling to follow the study's birth control requirements.I am not pregnant or breastfeeding.I am currently taking daily steroids higher than 0.5 mg/kg, methotrexate, or undergoing extracorporeal photopheresis.My cancer affects both my body and brain or just my brain.I have been diagnosed with an EBV+ disorder.I am 16 or older and can care for myself but not fully active; or I am under 16 and mostly active.
Research Study Groups:
This trial has the following groups:- Group 1: EBV+ CNS PTLD
- Group 2: EBV+ PTLD (inappropriate for first-line therapy or CD20-negative)
- Group 3: EBV+ sarcoma, including LMS, or smooth muscle tumors
- Group 4: EBV+ AID LPD
- Group 5: EBV+ PID LPD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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