FDA puts Atara INDs on clinical hold, same third-party facility to blame

Days after handing Atara Biotherapeutics a complete response letter, the FDA has placed a clinical hold on two of the company’s active INDs applications.

The INDs include the Ebvallo (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.

According to Atara, the clinical hold for Ebvallo is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the CRL for Ebvallo that was announced on January 16, 2025. ATA3219 is manufactured at a separate, fully compliant GMP-certified facility, however, the starting materials used in its production are affected by the compliance issues at the same third-party facility mentioned in the CRL.

Atara clarified that the issues which underlie both the CRL and the clinical hold are specific to the one referenced third-party manufacturing facility and do not affect the California facility owned by the Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies.

The holds allow for select subjects currently enrolled in the clinical studies to continue to receive treatment, but screening and enrollment of new participants in both programs have been paused. Atara says it has discussed and agreed upon the actions necessary to release the clinical holds with the FDA.