Phase 2
N=87
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
EBV-induced Lymphomas · EBV-associated Malignancies · Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01498484 ↗Enrolled (actual)
87
Serious AEs
52.9%
Results posted
Oct 2022
Primary outcome: Primary: Objective Response Rate (ORR) — 68.0; 50.0; 16.0; 14.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EBV-specific T cells (EBV-CTLs) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Atara Biotherapeutics
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
68.0; 50.0; 16.0; 14.3 | — |
| SECONDARY Overall Survival (OS) |
NA; 14.9; 12.3; NA | — |
| SECONDARY OS Rate at 12 Months |
68.0; 60.0; 50.3; 77.9 | — |
| SECONDARY OS Follow-up Time |
23.33; 14.88; 7.20; 16.0 | — |
| SECONDARY Time to Response (TTR) |
1.77; 3.32; 2.28; 1.76 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma or other EBV-associated malignancy.
OR
- Evaluable disease as demonstrated by clinical and/or radiologic studies with current or prior elevated blood levels of EBV DNA exceeding 500 copies/ml by quantitative real time polymerase chain reaction (PCR).
OR
- Persistent or recurrent elevations in levels of EBV DNA exceeding 500 copies/ml in patients previously treated for EBV-LPD with chemotherapy and/or rituximab who do not yet have clinically or radiologically evaluable disease but are at high risk of disease recurrence.
- EBV-specific T cells are available for adoptive immune cell therapy from a consenting third party donor. The third party EBV-CTLs to be administered will be selected on the basis of two criteria: 1) that they are matched for at least 2 HLA antigens and 2) that they are restricted by an allele shared with the EBV+ malignancy (if known), or with the donor in HSCT recipients, or patient in organ transplant or immunodeficient patients
- KPS or Lansky score ≥ 20.
- A life expectancy of at least 6 weeks.
- Adequate bone marrow, heart, lung, liver and kidney function at the time of treatment with EBV-specificT cells is initiated, including:
- 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) 0.5 mg/kg/day prednisone or its equivalent) as treatment
- Patients who are pregnant
- Patients with severe comorbidities, not related to their EBV-associated malignancy, that would be expected to preclude their survival for the 6 weeks required to assess response of T cell therapy
- Patients eligible for MSK protocol #16-803 (EBV-CTL-201)
Data sourced from ClinicalTrials.gov (NCT01498484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.