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CAR T-cell Therapy

Tabelecleucel for Post-Transplant Cancer (ALLELE Trial)

Phase 3
Recruiting
Research Sponsored by Atara Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD
Adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

ALLELE Trial Summary

This trial will test the safety and effectiveness of a new treatment for a type of cancer that can occur after organ transplantation.

Who is the study for?
This trial is for people who've had a solid organ or stem cell transplant and now have a condition called EBV+ PTLD, which hasn't improved after treatment with Rituximab alone or with chemotherapy. Participants must be in stable condition without the need for intensive support like ventilators, not have certain other diseases or ongoing severe infections, and women of childbearing age must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing tabelecleucel's effectiveness and safety in treating EBV+ PTLD among those who've undergone either solid organ transplants (like kidney, liver) or allogeneic hematopoietic cell transplants (stem cells from donors). The participants should have previously tried treatments that didn't work well enough.See study design
What are the potential side effects?
While specific side effects of tabelecleucel are not listed here, similar therapies can cause immune reactions, fatigue, fever, digestive issues and may affect blood counts. Organ function might also be impacted. Side effects vary by individual.

ALLELE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with EBV+ PTLD through a biopsy.
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My organs are working well.
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I am 16 or older and can care for myself but not fully active; or under 16 and mostly inactive.
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My platelet count is within the required range for my treatment group.
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My cancer shows up on scans and is actively growing.
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My previous treatment with rituximab alone or with chemotherapy for PTLD was unsuccessful.
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The sponsor has confirmed a matching treatment for me.
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My primary blood cancer is in remission after a stem cell transplant.
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My white blood cell count meets the trial's requirements.
Select...
I have had an organ transplant or bone marrow transplant.

ALLELE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) in the SOT or HCT cohort
Secondary outcome measures
Duration of response (DOR) in SOT and HCT cohorts separately
ORR and DOR in SOT and HCT cohorts combined
Overall survival (OS)
+4 more

ALLELE Trial Design

3Treatment groups
Experimental Treatment
Group I: SOT cohort -Subgroup BExperimental Treatment1 Intervention
Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.
Group II: SOT cohort -Subgroup AExperimental Treatment1 Intervention
Participants who have failed rituximab will receive IV tabelecleucel.
Group III: HCT cohortExperimental Treatment1 Intervention
Participants who have failed rituximab will receive IV tabelecleucel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tabelecleucel
2017
Completed Phase 3
~10

Find a Location

Who is running the clinical trial?

Atara BiotherapeuticsLead Sponsor
12 Previous Clinical Trials
639 Total Patients Enrolled
5 Trials studying Lymphoproliferative Disorders
343 Patients Enrolled for Lymphoproliferative Disorders
Aditi Mehta, DOStudy DirectorAtara Biotherapeutics
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Lymphoproliferative Disorders

Frequently Asked Questions

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

Has the United States Food and Drug Administration given its okay to tabelecleucel?

"There is existing clinical data that tabelecleucel is safe for use, thus it received a score of 3."

Answered by AI

Are there any current openings for patients who wish to enroll in this clinical trial?

"According to the website clinicaltrials.gov, this study is looking for more participants and was last updated on 6/23/2022."

Answered by AI

How many people are taking part in this research project?

"The trial sponsor, Atara Biotherapeutics, needs to enroll 66 eligible patients from multiple locations including Alberta Children's Hospital (Adults and Pediatrics) in Calgary, Alberta and UCLA Medical Center (Adults and Pediatrics) in Los Angeles, California."

Answered by AI

Is this research project being undertaken in multiple places across North America?

"Enrollment for this clinical trial is still open at 32 sites. These locations include cities such as Calgary, Los Angeles and Durham. If you are considering participating in this trial, please select the location nearest to you in order to reduce travel-related stressors."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor Scott and White Research Institute (Adults only)
What portion of applicants met pre-screening criteria?
Did not meet criteria
~9 spots leftby Mar 2025