Basic Information

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

GTO ID GTC0278
Trial ID NCT02601313
Disease Mantle Cell Lymphoma
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
PhasePhase2
Recruitment statusActive, Not Recruiting
TitleStudy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Year2015
CountryFrance|Germany|Netherlands|United States
Company sponsorKite, A Gilead Company
Other ID(s)KTE-C19-102|2015-005008-27|2023-506641-35
Vector information
Vectorlentivirus
ConstructscFv-CD28-CD3ζ

Clinical Result

Cohort1: dose level 1
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 68
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 93%(CR)
Adverse reactions 16/68(All-cause Mortality); 46/68(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified; Nervous system disorders; Psychiatric disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Vascular disorders)
Cohort2: dose level 2
Administration route intravenous infusion
Dosage 0.5E8 cells
Donor type Autologous
Pts 14
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 93%(CR)
Adverse reactions 4/14(All-cause Mortality); 8/14(Cardiac disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

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