IRB #

STUDY00020379

Title

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy
(ALLELE Study)

Principal Investigator

Eneida Nemecek

Study Purpose

The purpose of this study is to test how well the study product (tabelcleucel) works to treat EBV-PTLD following solid organ transplant or hematopoietic cell transplant in participants who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen.

If you participate, you will receive tabelecleucel, the study product, which contains special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. Your study product will be selected specifically for you from a library of frozen study product based on matching certain human leukocyte antigens (HLAs).

The study product is made by taking donor cells from a healthy person, growing the cells that fight EBV (EBV-CTLS) in a laboratory for several weeks, and then storing them in a freezer until they are matched to a patient in need of treatment. No genetic modifications are done to the cells. This process is repeated using multiple donors in order to create a library of study product.

Medical Condition(s)

EBV associated post-transplant proliferative disorder
solid organ transplant
allogeneic hematopoietic cell transplant
Rituximab

Eligibility Criteria

- Any age
- Prior solid tumor transplant of kidney, liver, heart, lung, pancreas, small bowel or any combination of these, or prior allogeneic hematopoietic cell transplant
- Diagnosis of EBV-PTLD
- Epstein-Barr Virus
- Treatment failure of rituximab

Age Range

0 - 120

Healthy Volunteers Needed

No

Duration of Participation

Up to 5 years total

Minors Included

Yes

Contact

Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) ­494-­1080 or trials@ohsu.ed

Sponsor

Atara Biotherapeutics

Recruitment End

01/01/2025

Compensation Provided

No


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