Trial Search Results

Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Atara Biotherapeutics

Intervention(s):

  • Biological: tabelecleucel

Eligibility


Inclusion Criteria:

   1. Any of the following diagnoses of EBV+ malignancies or disease:

      1. EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)

      2. EBV+ PTLD following solid organ transplant (SOT)

      3. Persistent EBV viremia and known or suspected immunodeficiency

      4. EBV+ LPD that has developed in the setting of an AID

      5. EBV+ LPD that has developed in the setting of a known or suspected PID

      6. EBV+ LMS

      7. EBV+ NPC

   2. The evidence of EBV positivity

   3. 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.

   4. Not eligible for any other Atara clinical development study

   5. For participants developing PTLD following allogeneic HCT for acute leukemia, the
   underlying acute leukemia must be in morphologic remission

   6. Adequate organ function per the following:

      1. Absolute neutrophil count >= 500/μL, with or without cytokine support

      2. Platelet count >= 20,000/μL, with or without transfusion support

   7. Participant or participant's representative is willing and able to provide written
   informed consent

Exclusion Criteria:

   1. Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell
   lymphoma

   2. Prior treatment with any investigational product within 4 weeks of first treatment
   with tabelecleucel, or within 5 half-lives from the most recent dose to first
   treatment with tabelecleucel

   3. Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1
   mg/kg/day of prednisone (or equivalent)

   4. Need for vasopressor or ventilatory support, unless deemed to be caused by the
   EBV-driven process that tabelecleucel is intended to treat

   5. Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or
   T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs])
   <= 4 weeks prior to first treatment with tabelecleucel

   6. Pregnancy

   7. 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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting