In adult patients with relapsed or refractory (R/R) mantle cell lymphoma
TECARTUS® has a
well-characterized
safety profile1
TECARTUS adverse reactions
Summary of adverse
reactions observed in ≥10%
of patients
treated with
TECARTUS in ZUMA-2
(Study 1, Cohorts 1 and 2) (N=82)1*
Adverse
Reactions
Any Grade (%)
Grade ≥3 (%)
Blood and Lymphatic System Disorders
Coagulopathy
Cardiac Disorders
10
2
Tachycardias
Bradycardias
Non-ventricular
arrhythmias
45
10
10
0
0
4
Gastrointestinal Disorders
Nausea
Constipation
Diarrhea
Abdominal pain
Oral pain
Vomiting
Dysphagia
35
29
28
17
16
13
10
1
0
5
0
0
0
2
General Disorders and
Administration
Site Conditions
Fever
Fatigue
Chills
Edema
Pain
94
48
41
35
17
15
1
0
2
2
Immune System Disorders
Cytokine release
syndrome
Hypogammaglobulinemia
91
16
18
1
Infections and Infestations
Infections with
pathogen unspecified
Viral infections
Bacterial infections
43
18
13
24
4
6
Metabolism and Nutrition Disorders
Decreased appetite
26
0
Musculoskeletal and Connective
Tissue
Disorders
Musculoskeletal pain
Motor dysfunction
37
17
2
4
Nervous System Disorders
Encephalopathy
Tremor
Headache
Aphasia
Dizziness
Neuropathy
51
38
35
20
18
13
24
2
1
7
6
2
Psychiatric Disorders
Insomnia
Delirium
Anxiety
21
18
16
0
5
0
Renal and Urinary Disorders
Renal insufficiency
Urine output decreased
18
11
9
1
Respiratory, Thoracic, and
Mediastinal
Disorders
Hypoxia
Cough
Dyspnea
Pleural effusion
40
38
24
21
20
0
6
5
Skin and Subcutaneous
Tissue Disorders
Rash
22
4
Vascular Disorders
Hypotension
Hypertension
Thrombosis
57
18
17
27
11
4
- 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) CRS in 12% of patients in Study 11†
- Neurologic toxicities (including ICANS) that were fatal or life-threatening occurred following treatment with TECARTUS. Neurologic events occurred in 80% (135/168) of patients with MCL, including ≥Grade 3 in 33% of patients in Study 1 (Cohorts 1, 2, and 3)1†
Summary of adverse
reactions observed in ≥10%
of patients
treated with
TECARTUS in ZUMA-2,‡
Cohort 3 (N=86)1
Adverse
Reactions
Any Grade (%)
Grade ≥3 (%)
Cardiac Disorders
Tachycardias
Non-ventricular
arrhythmias
20
13
1
3
Gastrointestinal Disorders
Nausea
Constipation
Diarrhea
Abdominal pain
Vomiting
Oral pain
33
28
24
19
15
14
1
0
0
1
0
1
General Disorders and
Administration
Site Conditions
Fever
Fatigue
Edema
Chills
94
43
21
19
17
2
0
0
Immune System Disorders
Cytokine release
syndrome
95
6
Infections and Infestations
Infections with
pathogen unspecified
Viral infections
Bacterial infections
Fungal infections
49
49
14
14
23
16
7
2
Metabolism and Nutrition Disorders
Decreased appetite
Weight decreased
24
12
9
1
Musculoskeletal and Connective
Tissue
Disorders
Musculoskeletal pain
Motor dysfunction
24
20
0
3
Nervous System Disorders
Encephalopathy
Tremor
Headache
Dizziness
Peripheral neuropathy
66
30
29
16
12
24
2
0
5
1
Psychiatric Disorders
Delirium
Insomnia
17
12
1
0
Renal and Urinary Disorders
Renal insufficiency
19
2
Respiratory, Thoracic, and
Mediastinal
Disorders
Hypoxia
Cough
Dyspnea
24
14
14
10
0
5
Skin and Subcutaneous
Tissue Disorders
Rash
16
0
Vascular Disorders
Hypotension
Hemorrhage
Thrombosis
Hypertension
52
16
13
10
8
5
3
2
There were no Grade 5 neurologic events and there was one Grade 5 CRS in ZUMA-21,2‡
Prolonged cytopenias have occurred following treatment with TECARTUS1
- Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion1
- At Day 30, 55% of patients had unresolved Grade 3 or higher cytopenias: 32% with thrombocytopenia, 42% with neutropenia, and 14% with anemia1
No new safety signals were seen at median follow-ups of 67.8 months (Cohort 1) and 72.3 months (Cohort 2)
*Combined data from Study 1 and Cohorts 1 and 2.
†Based on a safety population of 168 patients that includes BTKi-naïve patients.1
‡The ZUMA-2 trial corresponds to Study 1 in the US Prescribing Information; see Section 6.1 on page 11.
BTKi=Bruton tyrosine kinase inhibitor; CRS=cytokine release syndrome; ICANS=immune effector cell-associated neurotoxicity syndrome; MCL=mantle cell lymphoma.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing Information. Kite Pharma, Inc; 2026. 2. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. 3. Wang M, Munoz J, Goy A, et al. Three-year follow-up of KTE-X19 in patients with relapsed/refractory mantle-cell lymphoma, including high-risk subgroups, in the ZUMA-2 Study. J Clin Oncol. 2022;41:555-567. doi:10.1200/JCO.21.02370
Grade 3 or 4 lab abnormalities
Grade 3 or 4 laboratory
abnormalities occurring in
≥10% of patients in ZUMA-2
(Study 1, Cohorts 1 and 2)
following TECARTUS
infusion
(N=82)1
Grade 3 or 4 (%)
Leukopenia
95
Neutropenia
95
Lymphopenia
86
Thrombocytopenia
63
Anemia
55
Hypophosphatemia
30
Hypocalcemia
21
Blood uric acid increased
17
Hyponatremia
16
Aspartate aminotransferase increased
15
Alanine aminotransferase increased
15
Hypokalemia
10
Prolonged cytopenias have occurred following treatment with TECARTUS1
- Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion1
- At Day 30, 55% of patients had unresolved Grade 3 or higher cytopenias1
- 32% with thrombocytopenia
- 42% with neutropenia
- 14% with anemia
Grade 3 or 4 laboratory
abnormalities occurring in
≥10% of
patients in
ZUMA-2, Cohort 3 following
TECARTUS infusion
(N=86)1
Grade 3 or 4 (%)
Leukopenia
97
Lymphopenia
96
Neutropenia
91
Thrombocytopenia
44
Hypophosphatemia
40
Anemia
31
Hyperglycemia
29
Blood uric acid increased
28
Alanine aminotransferase increased
27
Hyponatremia
22
Calcium increased
12
Creatinine increased
12
Direct bilirubin increased
12
Magnesium increased
12
Aspartate aminotransferase increased
10
Hypocalcemia
10
No new safety signals were seen at median follow-ups of 67.8 months (Cohort 1) and 72.3 months (Cohort 2)
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing Information. Kite Pharma, Inc; 2026. 2. Wang M, Munoz J, Goy A, et al. Three-year follow-up of KTE-X19 in patients with relapsed/refractory mantle cell lymphoma, including high-risk subgroups, in the ZUMA-2 study. J Clin Oncol. 2023;41(3):555-567.