← Back to Search

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
Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects < 16 years
Must not have
Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with EBV+ PTLD through a biopsy.
Select...
I am 16 or older and can care for myself but not fully active; or under 16 and mostly inactive.
Select...
My previous treatment with rituximab alone or with chemotherapy for PTLD was unsuccessful.
Select...
My primary blood cancer is in remission after a stem cell transplant.
Select...
I have had an organ transplant or bone marrow transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition is either Burkitt lymphoma, classical Hodgkin lymphoma, or a T cell lymphoma.
Select...
I am not on high doses of steroids, methotrexate, or undergoing photopheresis.
Select...
I have a confirmed or suspected severe reaction from a transplant.
Select...
I need medication to maintain my blood pressure or a machine to help me breathe.
Select...
I am not pregnant, breastfeeding, and willing to use effective birth control.

Timeline

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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort SOT-R+C (C-SOT-R+C)Experimental Treatment1 Intervention
Participants with EBV+ PTLD following SOT that has failed both rituximab and chemotherapy will receive IV tabelecleucel.
Group II: Cohort SOT-R (C-SOT-R)Experimental Treatment1 Intervention
Participants with EBV+ PTLD following SOT that has failed rituximab will receive IV tabelecleucel.
Group III: Cohort HCT (C-HCT)Experimental Treatment1 Intervention
Participants with EBV+ PTLD following HCT that has failed rituximab containing regimen 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
13 Previous Clinical Trials
675 Total Patients Enrolled
5 Trials studying Lymphoproliferative Disorders
343 Patients Enrolled for Lymphoproliferative Disorders
Aditi Mehta, DOStudy DirectorAtara Biotherapeutics
3 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Lymphoproliferative Disorders
~6 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top