Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT02822495
• Date of registration: 30/06/2016
• Prospective Registration: Yes
• Primary sponsor: Atara Biotherapeutics
• Public title: Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
• Scientific title: Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
• Date of first enrolment: October 20, 2016
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT02822495
• Study type: Expanded Access

Countries of recruitment

United States

Contacts

• Name: Aditi Mehta, DO
• Affiliation: Atara Biotherapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Any of the following diagnoses of EBV+ malignancies or disease:

1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)

2. EBV+ PTLD following solid organ transplant (SOT)

3. Persistent EBV viremia and known or suspected immunodeficiency

4. EBV+ LPD that has developed in the setting of an AID

5. EBV+ LPD that has developed in the setting of a known or suspected PID

6. EBV+ LMS

7. EBV+ NPC

2. The evidence of EBV positivity

3. Relapsed or refractory disease, defined as failure to achieve response (ie, complete
response or partial response) or recurrent disease following first line therapy, ie,
systemic therapy for EBV-related malignancy or viremia for which there are no
appropriate therapies.

4. Not eligible for any other Atara clinical development study

5. For participants developing PTLD following allogeneic HCT for acute leukemia, the
underlying acute leukemia must be in morphologic remission

6. Adequate organ function per the following:

1. Absolute neutrophil count >= 500/µL, with or without cytokine support

2. Platelet count >= 20,000/µL, with or without transfusion support

7. Participant or participant's representative is willing and able to provide written
informed consent

Exclusion Criteria:

1. Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell
lymphoma

2. Prior treatment with any investigational product within 4 weeks of first treatment
with tabelecleucel, or within 5 half-lives from the most recent dose to first
treatment with tabelecleucel

3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1
mg/kg/day of prednisone (or equivalent)

4. Need for vasopressor or ventilatory support, unless deemed to be caused by the
EBV-driven process that tabelecleucel is intended to treat

5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or
T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs])
<= 4 weeks prior to first treatment with tabelecleucel

6. Pregnancy

7. Female of childbearing potential or male with a female partner of childbearing
potential, either of whom are unwilling to use a highly effective method of
contraception



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID)

Solid Organ Transplant Complications

Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID)

Lymphoma, AIDS-related

Lymphoproliferative Disorders

EBV+ Associated Lymphoma

Epstein-Barr Viremia

Epstein-Barr Virus (EBV) Infections

Leiomyosarcoma (LMS)

Nasopharyngeal Carcinoma (NPC)

EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)

Stem Cell Transplant Complications

Intervention(s)

Biological: tabelecleucel

Secondary ID(s)

ATA129-EAP-901

EBV-CTL-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors