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| ID | Type | Description | Link |
|---|---|---|---|
| EBV-CTL-201 | Other Identifier | Atara Biotherapeutics |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tabelecleucel | Biological | Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases. |
|
Inclusion Criteria:
Any of the following diagnoses of EBV+ malignancies or disease:
The evidence of EBV positivity
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.
Not eligible for any other Atara clinical development study
For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission
Adequate organ function per the following:
Participant or participant's representative is willing and able to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditi Mehta, DO | Atara Biotherapeutics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38625984 | Derived | Nikiforow S, Whangbo JS, Reshef R, Tsai DE, Bunin N, Abu-Arja R, Mahadeo KM, Weng WK, Van Besien K, Loeb D, Nasta SD, Nemecek ER, Zhao W, Sun Y, Galderisi F, Wahlstrom J, Mehta A, Gamelin L, Dinavahi R, Prockop S. Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol. Blood Adv. 2024 Jun 25;8(12):3001-3012. doi: 10.1182/bloodadvances.2023011626. |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D007239 | Infections |
| D008232 | Lymphoproliferative Disorders |
| D016483 | Lymphoma, AIDS-Related |
| D007890 | Leiomyosarcoma |
| D000077274 | Nasopharyngeal Carcinoma |
| D000081207 | Primary Immunodeficiency Diseases |
| D001172 | Arthritis, Rheumatoid |
| D008223 | Lymphoma |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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