Expanded Access Protocol for Tabelecleucel for Patients With EBV-Associated Viremia or Malignancies (ATA129-EAP-901)
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The primary objective of this protocol is to provide expanded access to tabelecleucel to patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (EBV+ PTLD), EBV+ primary immunodeficiency-associated lymphoproliferative disease (EBV+ PID LPD), EBV+ acquired immunodeficiency-associated LPD (EBV+ AID LPD), EBV+ leiomyosarcoma (EBV+ LMS), or EBV viremia, 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.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Any of the following diagnoses of EBV+ malignancies or disease:
EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
EBV+ PTLD following solid organ transplant (SOT)
Persistent EBV viremia and known or suspected immunodeficiency
EBV+ LPD that has developed in the setting of an AID
EBV+ LPD that has developed in the setting of a known or suspected PID
Any of the following evidence of EBV positivity:
Biopsy showing EBV+ disease
A combination of circulating EBV DNA and radiographic appearance consistent with an EBV+ malignancy (if biopsy is not clinically feasible in the opinion of the treating physician)
For patients with EBV viremia only: 2 serial serum EBV DNA assays performed at least 4 weeks apart showing detectable EBV viremia
Relapsed or refractory disease, defined as failure to achieve response (ie, complete response [CR] or partial response [PR]) or recurrence of disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia that includes an anti-CD20 antibody, except in subjects with CD20 negative disease. Reduction of immunosuppression will not be considered as first-line therapy. Patients with CD20+ PTLD following SOT must have failed anti-CD20 antibody therapy plus an additional systemic therapeutic agent, typically chemotherapy. Patients with CD20 negative PTLD must have failed first-line chemotherapy.
Not eligible for any other study supporting clinical development of tabelecleucel
For patients with PTLD in the allogeneic HCT setting, the underlying disease for which allogeneic HCT was performed is in morphologic remission
Adequate organ function per the following:
Absolute neutrophil count ≥ 500/μL, with or without cytokine support
Platelet count ≥ 20,000/μL, with or without transfusion support
Patient or patient's representative is willing and able to provide written informed consent
Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
Prior treatment with any investigational product within 4 weeks of Cycle 1 Day 1, or within 5 half-lives from the most recent dose to Cycle 1 Day 1
Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent)
Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other CTLs) ≤ 4 weeks prior to Cycle 1 Day 1
Female of childbearing potential or male with a female partner of childbearing potential, either of whom are unwilling to use a highly effective method of contraception