CompletedPhase 2

Therapeutic Effects of Epstein-Barr Virus Immune T-Lymphocytes Derived From a Normal HLA-Compatible Or Partially-Matched Third-Party Donor in the Treatment of EBV Lymphoproliferative Disorders and EBV-Associated Malignancies

United States87 participantsStarted 2011-12

Plain-language summary

This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen (HLA) partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.

Who can participate

SexALL

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Inclusion criteria

✓. Absolute neutrophil count (ANC) ≥ 1,000/µL, with or without GCSF support
✓. Platelets ≥ 20,000/µL
✓. Creatinine ≤ 2.0mg/dl
✓. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 3.0x and total bilirubin \< 2.5x the institutional upper limit of normal (ULN)
✓. Stable blood pressure and circulation not requiring pressor support
✓. Adequate cardiac function as demonstrated by EKG and/or echocardiographic evidence (may be performed within 30 days prior to treatment)

Exclusion criteria

✕. Patients developing EBV lymphomas or lymphoproliferative disorders following an allogeneic hematopoietic progenitor stem cell transplant (HSCT) (ie, marrow, PBSC, or umbilical cord blood).
✕. Patients developing EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant.
✕. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV.
✕. Patients who develop EBV lymphomas or lymphoproliferative diseases or other EBV-associated malignancy as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy.
✕. Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non-Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.

What they're measuring

Objective Response Rate (ORR)

Timeframe: From Day 1 through 65.3 months after Day 1 dose

Trial details

NCT IDNCT01498484

SponsorAtara Biotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07

Results submitted2022-06-30

View on ClinicalTrials.gov More EBV-induced Lymphomas trials