Axicabtagene Ciloleucel

YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines.

• YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.ICD-10: C85.90

• None. None.contraindicated

For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. ( 2.2 ) Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of YESCARTA. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and an H1-antihistamine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) The target YESCARTA dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. Each single infusion bag of YESCARTA contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells. 2.2 Administration YESCARTA is for autologous use only. The patient's identity must match the patient identifiers on the YESCARTA cassette and infusion bag. Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient. Preparing Patient for YESCARTA Infusion Confirm availability of YESCARTA prior to starting the lymphodepleting regimen. Pre-treatment Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of YESCARTA.

Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.3 ) Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.4 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following YESCARTA infusion. Monitor complete blood counts. ( 5.5 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.6 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA ( 5.7 ). In the event that a secondary malignancy occurs after treatment with YESCARTA, contact Kite at 1-844-454-KITE (5483). ( 5.7 ) 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system 1 ) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9% [see Adverse Reactions (6) ] . Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in Study 2, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days).

The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. ( 6.1 ) The most common Grade 3-4 laboratory abnormalities (≥ 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Kite at 1-844-454-KITE (5483) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in the WARNINGS AND PRECAUTIONS and in the ADVERSE REACTIONS sections reflect exposure to a single dose of YESCARTA in four clinical studies, including 168 patients with relapsed or refractory LBCL (Study 1), 108 patients with relapsed or refractory LBCL (Study 2), 146 patients with relapsed or refractory iNHL (including 124 with FL; Study 3), and 13 patients with relapsed or refractory primary CNS lymphoma (PCNSL) (Study 4).

8.1 Pregnancy Risk Summary There are no available data with YESCARTA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with YESCARTA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if YESCARTA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, YESCARTA is not recommended for women who are pregnant, and pregnancy after YESCARTA infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of YESCARTA in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YESCARTA and any potential adverse effects on the breastfed infant from YESCARTA or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy status of females with reproductive potential should be verified.

Metabolism

Following infusion of YESCARTA, anti-CD19 CAR T cells exhibited an initial rapid expansion followed by a decline to near baseline levels by 3 months. Peak levels of anti-CD19 CAR T cells occurred within the first 7 - 14 days after YESCARTA infusion.

1. 1Cytokine Release Syndrome4,37546%
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome1,98121%
3. 3Neurotoxicity1,36314%
4. 4Death9259.8%
5. 5Pyrexia8919.5%
6. 6Disease Progression7858.3%
7. 7Neutropenia4715.0%
8. 8Hypotension3884.1%
9. 9Diffuse Large B-cell Lymphoma3633.9%
10. 10Confusional State2993.2%
11. 11Febrile Neutropenia2933.1%
12. 12Encephalopathy2863.0%
13. 13Drug Ineffective2692.9%
14. 14Myelodysplastic Syndrome2612.8%
15. 15Fatigue2582.7%

The 10 most recently updated of 55 ClinicalTrials.gov registrations naming Axicabtagene Ciloleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
  Available · Expanded access · Kite, A Gilead Company
  NCT05776160updated 2026-06-12
• A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
  Recruiting · Phase 3 · Interventional · 400 enrolled · Lyell Immunopharma, Inc.
  NCT07188558updated 2026-06-08
• A Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.
  Recruiting · Early phase 1 · Interventional · 12 enrolled · Shenzhen Fosun Kairos Biotechnology Co., Ltd.
  NCT07606937updated 2026-06-05
• Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
  Enrolling by invitation · Observational · 1,000 enrolled · Kite, A Gilead Company
  NCT05041309updated 2026-05-14
• NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
  Recruiting · Phase 1 · Interventional · 24 enrolled · Washington University School of Medicine
  NCT07052305updated 2026-05-13
• CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
  Recruiting · Phase 2 · Interventional · 20 enrolled · Zhejiang Cancer Hospital
  NCT07538635updated 2026-05-13
• 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 · Phase 3 · Interventional · 550 enrolled · Kite, A Gilead Company
  NCT07479797updated 2026-05-12
• A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
  Recruiting · Phase 2 · Interventional · 20 enrolled · M.D. Anderson Cancer Center
  NCT06043323updated 2026-05-06
• Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
  Active not recruiting · Phase 3 · Interventional · 300 enrolled · Kite, A Gilead Company
  NCT05605899updated 2026-04-15
• Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
  Recruiting · Phase 2 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT06218602updated 2026-04-15

Frequently asked questions

How does Axicabtagene Ciloleucel work?

YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines.

What is Axicabtagene Ciloleucel used for?

According to FDA labeling, Axicabtagene Ciloleucel carries indications including: YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Axicabtagene Ciloleucel?

Axicabtagene Ciloleucel is classified as Antineoplastic cell and gene therapy, CD19-directed Chimeric Antigen Receptor, Genetically-modified Autologous T Cells, CD19 Receptor Interactions, Increased T Lymphocyte Activation.

What are the brand names for Axicabtagene Ciloleucel?

Axicabtagene Ciloleucel is marketed under brand names including Yescarta.

What are the contraindications for Axicabtagene Ciloleucel?

Axicabtagene Ciloleucel labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.