Trials / No Longer Available
No Longer AvailableNCT02822495
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Atara Biotherapeutics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
Summary
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Detailed description
Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10\^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
Conditions
- Epstein-Barr Virus (EBV) Infections
- Lymphoproliferative Disorders
- EBV+ Associated Lymphoma
- EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Epstein-Barr Viremia
- Lymphoma, AIDS-related
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID)
- Leiomyosarcoma (LMS)
- Nasopharyngeal Carcinoma (NPC)
- Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID)
- Solid Organ Transplant Complications
- Stem Cell Transplant Complications
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tabelecleucel | Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases. |
Timeline
- First posted
- 2016-07-04
- Last updated
- 2023-06-15
Source: ClinicalTrials.gov record NCT02822495. Inclusion in this directory is not an endorsement.