Also known as: axi-cel
Axicabtagene ciloleucel is an autologous CD19-directed CAR-T cell therapy marketed as Yescarta for large B-cell lymphoma settings after prior treatment failure. It is manufactured by engineering patient T cells and reinfusing them to target malignant B cells. The product received initial FDA approval in 2017 with expanded approvals later.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
Metabolic pathway scores consistently distinguished patients who developed severe neurologic events after CAR T-cell therapy across six clinical trials, surpassing traditional inflammatory markers in predictive performance.
Real-world data from over 300 large B-cell lymphoma patients treated with axicabtagene ciloleucel show response rates and survival outcomes remarkably similar to pivotal trial results, with 86% overall response rate and 74% one-year survival.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
Lyell Immunopharma has initiated dosing in its Phase III PiNACLE – H2H trial, comparing ronde-cel against approved CAR T-cell therapies for relapsed or refractory large B-cell lymphoma in second-line treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07538635 |
CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors. |
RECRUITING | PHASE2 |
| NCT07479797 |
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy |
RECRUITING | PHASE3 |
| NCT07326371 |
Glofitamab Combined With CAR-T Therapy in R/R DLBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07254754 |
Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma |
RECRUITING | PHASE2 |
| NCT07188558 |
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy |
RECRUITING | PHASE3 |
| NCT07042438 |
Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells |
RECRUITING | PHASE2 |
| NCT06935136 |
Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma |
NOT_YET_RECRUITING | NA |
| NCT06826118 |
Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma |
RECRUITING | PHASE2 |
| NCT06609304 |
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma |
RECRUITING | PHASE4 |
| NCT06550141 |
Emapalumab Prevention of CAR-T Cell Associated Toxicities |
RECRUITING | PHASE2 |
