Study of Allogeneic EBV-CTLs in EBV-Associated Lymphomas and Lymphoproliferative Disorders

Description

This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA) partially-matched third-party allogeneic EBV-CTLs for the treatment of EBV lymphomas or Lymphoproliferative Disorders. Eligible patients have primary or acquired immunodeficiency, and include those that have received allogeneic Hematopoietic Cell Transplants (alloHCT) or Solid Organ Transplants (SOT) and are not eligible for any other trials supporting the development of EBV-CTLs.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Biological: Epstein-Barr Virus Cytotoxic T Lymphoctyes (EBV-CTLs)

Specialties

  • Internal Medicine: Hematology/Oncology
  • Nursing: Hematology/Oncology
  • Oncology: Leukemia/Lymphoma
  • Medical Student: Hematology/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Lymphoma
  • Lymphoproliferative Disorders

Study ID

Atara Biotherapeutics -- EBV-CTL-201

Status

Available

Trial ID

NCT02822495

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Atara Biotherapeutics

Inclusion Criteria

    1. A diagnosis of EBV+ LPD or lymphoma based on: 1. Biopsy showing EBV+ LPD/lymphoma, OR 2. A combination of circulating EBV DNA AND radiographic appearance consistent with an EBV+ LPD or malignancy, if biopsy is not clinically feasible 2. EBV-lymphoma or LPD post-alloHCT, post-SOT, or in the context of a documented underlying primary/congenital or acquired immunodeficiency (eg, HIV) 3. Availability of appropriate HLA partially-matched and restricted EBV-CTLs 4. No other comparable or satisfactory therapies available for treatment of EBV+ disease 5. Not eligible for any other trials supporting development of EBV-CTLs 6. Eastern Cooperative Oncology Group (ECOG) performance status ? 3 for patients aged > 16 years Lansky score ? 20 for patients ? 16 years 7. For patients with PTLD in the alloHCT setting, the underlying disease for which alloHCT transplant was performed is in morphologic remission 8. Adequate organ function per the following (unless deemed to be caused by the underlying EBV-driven process which EBV-CTLs are intended to treat, or its prior therapy): 1. Absolute neutrophil count ? 500/?L, with or without cytokine support 2. Platelet count ? 50,000/?L, with or without transfusion support platelet count < 50,000/?L but ? 20,000/?L, with or without transfusion support, is permissible if the patient has not had Grade ? 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 4.03). 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3× the upper limit of normal (ULN) and total bilirubin < 2.5×ULN up to 5×ULN is acceptable if the elevation is considered due to PTLD involvement of the liver 4. Creatinine < 3×ULN 9. Patient or patient's representative is willing and able to provide written informed consent

Exclusion Criteria

    1. Need for antimetabolite agents (eg, azathioprine, methotrexate), or extracorporeal photopheresis 2. Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process which EBV-CTLs are intended to treat 3. Antithymocyte globulin or similar anti-T cell antibody therapy ? 4 weeks prior to Cycle 1 Day 1 4. Pregnancy, except when EBV-CTLs are clearly needed (see Section 8.1.6) 5. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception 6. Inability to comply with study procedures

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
The Childrens Hospital at Montefiore - Bronx, New York 40.3 miles None None None

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