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Tab‑cel®

Tabelecleucel, tab‐cel® – Investigational PTLD T-cell immunotherapy

Tabelecleucel, tab‐cel® is an off-the-shelf, allogeneic T-cell immunotherapy in Phase 3 studies for patients with EBV+ PTLD (Epstein-Barr virus associated post-transplant lymphoproliferative disease). Additional studies are focusing on EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC) and chronic active EBV. PTLD is a type of cancer or lymphoma that may occur after bone marrow or organ transplant.

In February 2015, the FDA granted tabelecleucel Breakthrough Therapy Designation for Epstein-Barr virus associated post-transplant lymphoproliferative disorder following allogeneic hematopoietic cell transplant (HCT), and in October 2016, tabelecleucel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. In addition, tab‐cel® has orphan status in the U.S. and EU.

Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant or solid organ transplant (ALLELE study), and Atara recently initiated a Phase 1/2 study in NPC. Tab-cel® is also available to eligible patients with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options through an expanded access program.

If you are interested in learning more about our ongoing clinical studies, please contact us at ClinicalStudies@atarabio.com.

Post-Transplant Lymphoproliferative Disease (PTLD)

Post-transplant lymphoproliferative disease (PTLD) is a type of cancer or lymphoma that may occur after bone marrow or organ transplant.

A patient who receives a transplant must take medications to suppress their immune system (immunosuppression) so that their body will not reject the new bone marrow or organ. When the immune system is suppressed, it is easier to become sick. Sometimes when a transplant patient is infected with Epstein-Barr virus (EBV), the virus may cause a serious cancer of the blood known as PTLD.

EBV is a common virus that infects over 90% of people in the world. For most healthy individuals, it causes common cold like symptoms and then stays in the body but is usually controlled by the immune system, so there are no further symptoms after the initial infection. If a person has a suppressed immune system, the EBV can become reactivated and cause an uncontrolled growth of cells in the patient’s lymph nodes and other organs. When abnormal cells multiply out of control, it may result in cancer.

PTLD is a common cancer of the blood after transplant but is still considered a rare disease that only occurs in a small percentage of transplant patients. Rates of PTLD cancer are higher for people who have bone marrow and organ transplants that require higher levels of immunosuppression.

In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition.

  • Median overall survival in patients with EBV+ PTLD following HCT who have failed first line therapy is 16-56 days.(1)
  • One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.


(1) Expected median survival for patients with EBV+ PTLD following HCT who have failed rituximab first line therapy is 16 to 56 days; Atara estimated 1-year survival based on analysis of Ocheni S, et al. EBV reactivation and post transplant lymphoproliferative disorders following allogeneic SCT. Bone Marrow Transplantation. 2008 Aug;42(3):181-6; Fox CP, et al. EBV-associated post-transplant lymphoproliferative disorder following in vivo T-cell-depleted allogeneic transplantation: Clinical features, viral load correlates and prognostic factors in the rituximab era. Bone Marrow Transplant. 2014;49(2):280-6.

Tab-cel® (tabelecleucel)

Indication Preclinical Phase 1 Phase 2 Phase 3
RR EBV+ PTLD following HCT
  • Tab-cel® (tabelecleucel), Atara’s most advanced T-cell immunotherapy in development, is an investigational treatment for Epstein-Barr
    virus (EBV) associated post-transplant lymphoproliferative disease (EBV+ PTLD), as well as other EBV associated hematologic and
    solid tumors.
  • Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
    after failure of rituximab (NCT03392142, ALLELE study).
RR EBV+ PTLD following SOT
  • Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following solid organ transplant (SOT) after failure of rituximab or rituximab and chemotherapy (NCT03394365, ALLELE study).
Nasopharyngeal carcinoma (NPC)
  • Tab-cel® in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), is in Phase 1b/2 clinical development for patients with platinum-resistant or recurrent EBV-associated NPC (NCT03769467).
EBV+ cancers
  • Phase 2 multi-cohort study planned including EBV+ PTLD with CNS involvement, EBV+ PID/AID LPD, EBV+ LMS and other potential EBV-associated diseases.
Indication Phase
RR EBV+ PTLD following HCT Phase 3
  • Tab-cel® (tabelecleucel), Atara’s most advanced T-cell immunotherapy in development, is an investigational treatment for Epstein-Barr
    virus (EBV) associated post-transplant lymphoproliferative disease (EBV+ PTLD), as well as other EBV associated hematologic and
    solid tumors.
  • Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
    after failure of rituximab (NCT03392142, ALLELE study).
RR EBV+ PTLD following SOT Phase 3
  • Tab-cel® is in Phase 3 clinical development for the treatment of EBV+ PTLD following solid organ transplant (SOT) after failure of rituximab or rituximab and chemotherapy (NCT03394365, ALLELE study).
Nasopharyngeal carcinoma (NPC) Phase 2
  • Tab-cel® in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), is in Phase 1b/2 clinical development for patients with platinum-resistant or recurrent EBV-associated NPC (NCT03769467).
EBV+ cancers Phase 1
  • Phase 2 multi-cohort study planned including EBV+ PTLD with CNS involvement, EBV+ PID/AID LPD, EBV+ LMS and other potential EBV-associated diseases.

EBV at a Glance

Persistent lifelong, asymptomatic infection

~95%


Of adults carry EBV by age 40

Implicated in a wide range of cancers and autoimmune diseases

EBV+ PTLD – Attractive Ultra-Rare Disease Market

Clinical Studies

Clinical Studies Aimed at Addressing Unmet Medical Needs

There is a high unmet medical need for additional effective immunotherapies. We believe our novel treatments currently in clinical development have the potential to change the way we approach certain life-threatening diseases.
Clinical Studies Aimed at Addressing Unmet Medical Needs