FDA Issues Clinical Hold on Tabelecleucel Monotherapy, Anti-CD19 CAR T-Cell Therapy INDs

The FDA has implemented a clinical hold on two active Investigational New Drug (IND) applications from Atara Biotherapeutics, Inc., Atara has announced in a press release.

The clinical hold concerns foremost Atara’s program on tabelecleucel monotherapy for Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease (PTLD) in adult and pediatric patients aged two years and older. This drug is under development by Atara as Ebvallo.

During the prelicense inspection of the third-party manufacturing facility referenced in the Ebvallo Complete Response Letter (CRL), released on January 16, 2025, Good Manufacturing Practice (GMP) compliance issues were identified. The issues have not been adequately addressed and have led to the FDA’s clinical hold on Ebvallo.

The second Atara program affected by the clinical hold is ATA3219, an allogeneic CD19-targeted chimeric antigen receptor (CAR) T-cell therapy for non-Hodgkin lymphoma and systemic lupus erythematosus. ATA3219 is manufactured at a GMP-compliance–certified facility different from Ebvallo’s, but the compliance issues at the same third-party facility cited in the Ebvallo CRL affect the base materials used for its production.

The issues leading to the clinical hold from the FDA pertain only to the third-party manufacturing facility that was named in the CRL. They do not concern the facility in Thousand Oaks, California, operated by FUJIFILM Diosynth Biotechnologies, another third-party manufacturer utilized by Atara.

Under the FDA clinical hold, screening and enrollment of new participants for the two affected Atara programs has been halted. However, specific participants who are already enrolled in clinical studies who might benefit from these treatments can continue to receive them according to the ongoing study protocols.

Atara is currently cooperating with the FDA to quickly remedy the issues behind the clinical hold.

“We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs,” stated Atara President and Chief Executive Officer Cokey Nguyen, PhD.

Reference

Atara Biotherapeutics provides update on clinical programs related to Ebvallo™ (tabelecleucel) and ATA3219. Press Release. Atara Biotherapeutics. January 21, 2025. Accessed January 23, 2025.