Last reviewed 2026-04-20 · How we verify

Kymriah (TISAGENLECLEUCEL)

Kymriah modifies a patient's T-cells to recognize and attack cancer cells expressing the CD19 protein.

Kymriah (tisagenlecleucel) is a CD19-directed Chimeric Antigen Receptor (CAR) T-cell therapy developed by Novartis Pharmaceuticals Corporation. It works by modifying a patient's T-cells to recognize and attack cancer cells expressing the CD19 protein. Kymriah is approved to treat various types of blood cancers, including B-cell precursor acute lymphoblastic leukemia and relapsed or refractory large B-cell lymphoma. The commercial status of Kymriah is patented, and it is not yet available as a generic product. Key safety considerations include cytokine release syndrome and neurotoxicity.

At a glance

Mechanism of action

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment which recognizes CD19 and is fused to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta. The CD3 zeta component is critical for initiating T cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of KYMRIAH. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T cell expansion, activation, target cell elimination, and persistence of the KYMRIAH cells.

Approved indications

• B-cell precursor acute lymphoblastic leukemia (ALL)
• relapsed or refractory (r/r) large B-cell lymphoma
• diffuse large B-cell lymphoma (DLBCL) not otherwise specified
• high grade B-cell lymphoma
• DLBCL arising from follicular lymphoma
• primary central nervous system lymphoma
• relapsed or refractory follicular lymphoma (FL)
• relapsed or refractory (r/r) large B-cell lymphoma
• relapsed or refractory (r/r) follicular lymphoma (FL)
• B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

Boxed warnings

• WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH 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)]. Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed [see Warnings and Precautions (5.2)]. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH [see Warnings and Precautions (5.8)]. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGICAL TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. ( 2.2 , 2.3 , 5.1 ) Neurological toxicities, including severe or life-threatening reactions, occurred following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care and/or corticosteroids as needed. ( 5.2 ) T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies, including KYMRIAH. ( 5.8 )

Common side effects

• Infections-pathogen unspecified
• Hypogammaglobulinemia
• Fever
• Decreased appetite
• Viral infectious disorders
• Headache
• Febrile neutropenia
• Hemorrhage
• Musculoskeletal pain
• Vomiting
• Encephalopathy
• Diarrhea

Drug interactions

• HIV nucleic acid tests (NATs)

Key clinical trials

• A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (PHASE3)
• Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (PHASE3)
• Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (PHASE2)
• A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
• Long-term Follow up Local Registry Study of Kymriah in South Korea
• Study of Out of Specification for Tisagenlecleucel (PHASE3)
• Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies (PHASE1)
• Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

Patents

Primary sources

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