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

Two active Investigational New Drug (IND) applications from Atara Biotherapeutics, Inc., have been placed on clinical hold by the FDA, Atara announced in a press release.

The clinical hold concerns 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. The treatment is being developed by Atara as Ebvallo.

At a third-party manufacturing facility for Ebvallo, referenced in the Ebvallo Complete Response Letter (CRL) released on January 16, 2025, Good Manufacturing Practice (GMP) compliance issues were identified during the prelicense inspection. The FDA implemented the clinical hold on Ebvallo due to these issues having not been sufficiently addressed.

Also affected by the clinical hold is Atara’s program for ATA3219, an allogeneic CD19-targeted chimeric antigen receptor (CAR) T-cell therapy to treat non-Hodgkin lymphoma and systemic lupus erythematosus. ATA3219 and Ebvallo are manufactured at different facilities and the ATA3219 site is GMP-compliance–certified but the base materials for ATA3219 production are affected by the compliance issues at the third-party facility cited in the Ebvallo CRL.

The issues leading to the clinical hold from the FDA refer only to the third-party manufacturing facility cited in the CRL. They do not pertain to the FUJIFILM Diosynth Biotechnologies facility in Thousand Oaks, California, another third-party manufacturing site used by Atara.

For the two Atara programs under the FDA clinical hold, screening and enrollment of new participants for clinical studies is currently paused. However, participants already enrolled who might clinically benefit from these investigation therapies may continue to receive them in keeping with the ongoing study protocols.

Atara is working with the FDA to quickly resolve the issues which led to the hold’s implementation.

“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.