Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A multicenter Expanded Access Program (EAP) study of Tabelecleucel for patients with relapsed or refractory (r/r) Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT)

Next Previous
Trial Profile

A multicenter Expanded Access Program (EAP) study of Tabelecleucel for patients with relapsed or refractory (r/r) Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT)

Status: Suspended
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 10 Mar 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Tabelecleucel (Primary)
  • Indications Lymphoproliferative disorders; Post-transplant lymphoproliferative disorder
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Sponsors Atara Biotherapeutics

Most Recent Events

  • 07 Mar 2025 According to an Atara Biotherapeutics Media Release, company is currently undertaking efforts to support the third-party manufacturer in addressing the FDA's requests in order to lift the hold and support BLA resubmission; the Company anticipates providing a regulatory update in the second quarter of 2025.
  • 21 Jan 2025 Status changed from recruiting to suspended. The U.S. FDA has placed a clinical hold which is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection. Specifically identified subjects currently enrolled in the clinical study who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocol but screening and enrollment of new participants have been paused.
  • 05 Jun 2023 According to an Atara Biotherapeutics Media Release, results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top