Clinical Trials

Expanded Access

Expanded Access Program

Atara Biotherapeutics is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer and autoimmune diseases. Our commitment is to make every effort to support patients in need of treatment options.

Expanded Access Mechanisms

(updated Nov 2022)

At this time, patients in the US and EU have the possibility to access tabelecleucel through one of our clinical trials.

302 Clinical Trial

205 Clinical Trial

Process for Requesting Expanded Access

In the US, for the next 3-6 months, the expanded access 901 protocol and consideration of single patient use requests of tabelecleucel are temporarily paused.

Periodic updates regarding the resumption of this program will be provided on this website.

In the EU, Atara will consider providing an individual patient with access to investigational product candidates through an expanded access study. A treating physician may request information about how to apply for access to one of Atara’s investigational product candidates by contacting Atara. Atara will use reasonable efforts to respond and acknowledge each request within one (1) business day of submission. All physicians who receive Atara’s investigational product candidate are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.

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Review Criteria for Expanded Access Requests

Atara will use the following criteria to review each request:

  • The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to treat the disease or condition.
  • The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated.
  • Providing the investigational product candidate for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the investigational product candidate for the expanded access use or otherwise compromise the potential development of the investigational product candidate for the expanded access use.
  • There is a plausible scientific rationale which suggests that the patient may benefit from treatment with the investigational product candidate.
  • The investigational product candidate must be part of an active clinical development program at Atara and there must be an adequate supply of such investigational product candidate. If there is a protocol under an existing IND for which the patient is eligible, then the patient should be provided the option to enroll in this protocol.
  • There is a regulatory mechanism in the country or region to support expanded access for the investigational product candidate.

Each request will be evaluated individually to assess the above criteria.