Brexucabtagene Autoleucel

TECARTUS, 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.

• TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).ICD-10: C85.90, C95.90

• None. None.contraindicated

For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of TECARTUS. ( 2.2 ) Verify the patient's identity prior to infusion. ( 2.2 ) Premedicate with acetaminophen and diphenhydramine. ( 2.2 ) Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) MCL: 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 ) ALL: dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. Recommended Dosage for MCL 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. Recommended Dosage for ALL The target dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells. 2.2 Administration TECARTUS is for autologous use only. The patient's identity must match the patient identifiers on the TECARTUS cassette and infusion bag. Do not infuse TECARTUS if the information on the patient-specific label does not match the intended patient. Preparing Patient for TECARTUS Infusion Confirm availability of TECARTUS prior to starting the lymphodepleting chemotherapy regimen.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome: Administer treatment per institutional standards. ( 5.3 ) Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.4 ) Severe Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.5 ) Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following TECARTUS infusion. Monitor complete blood counts. ( 5.6 ) Hypogammaglobulinemia: Monitor and provide replacement therapy. ( 5.7 ) Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. In the event that a secondary malignancy occurs after treatment with TECARTUS, contact Kite at 1-844-454-KITE (5483). ( 5.8 ) 5.1 Cytokine Release Syndrome Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with TECARTUS. CRS occurred in 93% (157/168) of patients with MCL, including ≥ Grade 3 (Lee 2014 grading system 1 ) CRS in 12% of patients in Study 1. Among the patients with MCL who died after receiving TECARTUS, 1 patient had a fatal CRS event. The median time to onset of CRS was 4 days (range: 1 to 13 days). The median duration of CRS was 7 days (range: 1 to 50 days). CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system 1 ) CRS in 26% of patients. Three patients with ALL had ongoing CRS events at the time of death.

The most common non-laboratory adverse reactions (incidence greater than or equal to 20%) are: MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. ( 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. Study 1 (Relapsed/Refractory Mantle Cell Lymphoma) Cohort 1 and 2 The safety of TECARTUS in patients with relapsed/refractory Mantle cell lymphoma (MCL) was evaluated in a single-arm study (Study 1; Cohorts 1 and 2) in which a total of 82 patients received a single dose of TECARTUS (2 × 10 6 or 0.5 × 10 6 anti-CD19 CAR T cells/kg) [see Clinical Studies (14.1) ] .

8.1 Pregnancy Risk Summary There are no available data with TECARTUS use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TECARTUS to assess whether TECARTUS can cause fetal harm when administered to a pregnant woman. It is not known if TECARTUS has the potential to be transferred to the fetus. Based on the mechanism of action of TECARTUS, if the transduced cells cross the placenta, they may cause fetal toxicity, including B cell lymphocytopenia. Therefore, TECARTUS is not recommended for women who are pregnant. Pregnancy after TECARTUS 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 TECARTUS 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 TECARTUS and any potential adverse effects on the breastfed infant from TECARTUS 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 (target dose of 2 × 10 6 anti-CD19 CAR T cells/kg) of TECARTUS in Study 1, 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 15 days after TECARTUS infusion.

1. 1Cytokine Release Syndrome881—
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome573—
3. 3Death196—
4. 4Neurotoxicity195—
5. 5Pyrexia119—
6. 6Hypotension109—
7. 7Disease Progression100—
8. 8Fatigue89—
9. 9Febrile Neutropenia80—
10. 10Confusional State64—
11. 11Squamous Cell Carcinoma Of Skin57—
12. 12Myelodysplastic Syndrome54—
13. 13Encephalopathy52—
14. 14Drug Ineffective50—
15. 15Tachycardia50—

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Brexucabtagene Autoleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma
  Active not recruiting · Early phase 1 · Interventional · 22 enrolled · M.D. Anderson Cancer Center
  NCT05495464updated 2026-05-20
• 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
• Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
  Recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT06287229updated 2026-04-24
• Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
  Completed · Phase 1 · Phase 2 · Interventional · 95 enrolled · Kite, A Gilead Company
  NCT02625480updated 2026-04-09
• Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
  Available · Expanded access · Kite, A Gilead Company
  NCT05776134updated 2026-04-08
• Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
  Recruiting · Phase 2 · Interventional · 60 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT06144606updated 2026-03-31
• Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
  Recruiting · Phase 2 · Interventional · 60 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT06553872updated 2026-03-31
• Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
  Completed · Phase 2 · Interventional · 105 enrolled · Kite, A Gilead Company
  NCT02601313updated 2026-03-18
• Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
  Terminated · Phase 2 · Interventional · 19 enrolled · Kite, A Gilead Company
  NCT05537766updated 2026-03-10
• MT2017-45: CAR-T Cell Therapy for Heme Malignancies
  Active not recruiting · Phase 2 · Interventional · 150 enrolled · Masonic Cancer Center, University of Minnesota
  NCT03642626updated 2026-01-23

Frequently asked questions

How does Brexucabtagene Autoleucel work?

TECARTUS, 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 Brexucabtagene Autoleucel used for?

According to FDA labeling, Brexucabtagene Autoleucel carries indications including: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brexucabtagene Autoleucel?

Brexucabtagene Autoleucel is classified as Antineoplastic cell and gene therapy, CD19-directed Antibody Interactions, Immunologic Activity Alteration.

What are the brand names for Brexucabtagene Autoleucel?

Brexucabtagene Autoleucel is marketed under brand names including Tecartus.

What are the contraindications for Brexucabtagene Autoleucel?

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