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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 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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My organs work well, unless the issue is caused by my EBV-related disease.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

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.

Find a Location

Who is running the clinical trial?

Atara BiotherapeuticsLead Sponsor
12 Previous Clinical Trials
515 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

Tabelecleucel (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04554914 — Phase 2
Stem Cell Transplant Complications Research Study Groups: EBV+ CNS PTLD, EBV+ PTLD (inappropriate for first-line therapy or CD20-negative), EBV+ sarcoma, including LMS, or smooth muscle tumors, EBV+ AID LPD, EBV+ PID LPD
Stem Cell Transplant Complications Clinical Trial 2023: Tabelecleucel Highlights & Side Effects. Trial Name: NCT04554914 — Phase 2
Tabelecleucel (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04554914 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its stamp of approval to Tabelecleucel?

"Tabelecleucel's safety was measured at a level 2, meaning that while there is data to suggest its safety, the efficacy of this medication has yet to be determined."

Answered by AI

What is the capacity of participants for this experiment?

"Affirmative. Clinicaltrials.gov confirms that this study, which was initially published on July 14th 2021 is actively enrolling eligible patients. The study plans to recruit 228 individuals from 23 distinct sites."

Answered by AI

What is the scope of locations participating in this trial?

"Currently, this clinical trial is running out of 23 locations. Not only are there sites in Los Angeles, Palo Alto and Minneapolis but also 20 other cities. To reduce the strain on patients participating, it could be beneficial to choose a nearby site for convenience."

Answered by AI

Are there any openings to join this experiment currently?

"Clinicaltrials.gov confirms that this medical trial is actively recruiting, with the initial post going live on July 14th 2021 and a recent update posted on November 9th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
65+
What site did they apply to?
Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)
MD Anderson (Adults and Pediatrics)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have tried 4 medicines and they have not worked and I hope that this clinical trials will help my condition.
PatientReceived no prior treatments
~100 spots leftby Jun 2027