High Rate of Durable Complete Remission in Follicular Lymphoma after CD19 CAR-T cell Immunotherapy

Alexandre V. Hirayama, Jordan Gauthier, Kevin A. Hay, Jenna M. Voutsinas MPH, Qian Wu, Barbara S. Pender, Reed M. Hawkins, Aesha Vakil, Rachel N. Steinmetz, Stanley R. Riddell, David G. Maloney and Cameron J. Turtle

Key Points

  • CD19 CAR-T cell immunotherapy results in high complete remission rates in follicular lymphoma with or without transformation.

  • Sustained remissions were observed in all patients with follicular lymphoma without transformation achieving complete remission.


Patients with follicular lymphoma (FL) with early relapse after initial chemoimmunotherapy, refractory disease, or histologic transformation (tFL) have limited progression-free and overall survival. We report efficacy and long-term follow-up of 21 patients with relapsed/refractory (R/R) FL (n = 8) and tFL (n = 13) treated on a phase 1/2 clinical trial with cyclophosphamide and fludarabine lymphodepletion followed by infusion of 2x106 CD19-directed chimeric antigen receptor-modified T (CAR-T) cells/kg. The complete remission (CR) rates by the Lugano criteria were 88% and 46% for patients with FL and tFL, respectively. All patients with FL who achieved CR remained in remission at a median follow-up of 24 months. The median duration of response for patients with tFL was 10.2 months at a median follow-up of 38 months. Cytokine release syndrome occurred in 50% and 39%, and neurotoxicity in 50% and 23% of patients with FL and tFL, respectively, with no severe adverse events (grade {greater than or equal to} 3). No significant differences in CAR-T cell in vivo expansion/persistence were observed between FL and tFL patients. CD19 CAR-T cell immunotherapy is highly effective in adults with clinically aggressive R/R follicular lymphoma with or without transformation, with durable remission in a high proportion of FL patients. This trial is registered at (NCT01865617).

  • Submitted April 2, 2019.
  • Revision received June 7, 2019.
  • Accepted May 22, 2019.