Basic Information

Gene symbol CD19 Synonyms B4, CVID3 Type of gene protein-coding
Description CD19 molecule

GTO ID GTC0281
Trial ID NCT02614066
Disease B-Cell Acute Lymphoblastic Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment KTE-X19|Tecartus|Brexucabtagene autoleucel
Location approved US, EU, UK, Australia, Canada
Generation2nd
PhasePhase1|Phase2
Recruitment statusActive, Not Recruiting
TitleA Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
Year2015
CountryUnited States
Company sponsorKite, A Gilead Company
Other ID(s)KTE-C19-103|2015-005009-35
Vector information
Vectorlentivirus
ConstructscFv-CD28-CD3ζ

Clinical Result

Cohort1: phase1_dose level 1
Administration route intravenous infusion
Dosage 2E6 cells/kg, single infusion
Donor type Autologous
Pts 6
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions 5/6(All-couse mortality); 6/6(Cardiac disorders; General disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
Cohort2: phase1_dose level 2
Administration route intravenous infusion
Dosage 1E6 cells/kg, single infusion
Donor type Autologous
Pts 23
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions 15/28(All-couse mortality); 21/23(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Immune system disorders; Infections and infestations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
Cohort3: phase1_dose level 3
Administration route intravenous infusion
Dosage 0.5E6 cells/kg, single infusion
Donor type Autologous
Pts 16
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions 15/20(All-couse mortality); 12/16(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Investigations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
Cohort4: phase2_dose level 2
Administration route intravenous infusion
Dosage 1E6 cells/kg, single infusion
Donor type Autologous
Pts 55
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 0.564(CR)
Adverse reactions 30/71(All-couse mortality); 41/55(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; Immune system disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Investigations; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Vascular disorders)

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