Last reviewed 2026-05-13 · How we verify

Tecartus

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids [see Dosage and Administration (2.2 , 2.3) , Warnings and Precautions (5.1) ] . Neurologic toxicities, includin

Common side effects

• Cytokine release syndrome
• Fever
• Infection with pathogen unspecified
• Encephalopathy
• Hypoxia
• Tachycardia
• Dyspnea
• Fatigue
• Bacterial infections
• Viral infections
• Respiratory failure
• Aphasia

Serious adverse events

• Cytokine release syndrome
• Encephalopathy
• Fever
• Infection with pathogen unspecified
• Hypoxia
• Tachycardia
• Bacterial infections
• Viral infections
• Fungal infections
• Seizure

Key clinical trials

• Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) (PHASE2)
• Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
• Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL (PHASE2)
• Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL) (PHASE2)
• MT2017-45: CAR-T Cell Therapy for Heme Malignancies (PHASE2)
• Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (PHASE2)
• Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (PHASE2)
• Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tecartus CI brief — competitive landscape report
• Tecartus updates RSS · CI watch RSS
• H. Lee Moffitt Cancer Center and Research Institute portfolio CI