Basic Information

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

GTO ID GTC0450
Trial ID NCT03624036
Disease Chronic Lymphocytic Leukemia | Small Lymphocytic 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
PhasePhase1
Recruitment statusTerminated
TitleSafety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Year2018
CountryItaly|United States
Company sponsorKite, A Gilead Company
Other ID(s)KTE-C19-108|2018-001923-38
Vector information
Vectorlentivirus
ConstructscFv-CD28-CD3ζ

Clinical Result

Cohort1: CLL_dose level 1
Administration route intravenous infusion
Dosage 1E6 cells/kg
Donor type Autologous
Pts 6
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Number of Participants Experiencing Dose Limiting Toxicities:0
Adverse reactions 2/7(All-couse mortality); 4/6(Cardiac disorders; General disorders; Nervous system disorders; Psychiatric disorders; Vascular disorders)
Cohort2: CLL_dose level 2
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Number of Participants Experiencing Dose Limiting Toxicities:0
Adverse reactions 3/3(All-couse mortality); 2/3(Gastrointestinal disorders; General disorders; Infections and infestations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified; Vascular disorders)
Cohort3: CLL/SLL_dose level 1
Administration route intravenous infusion
Dosage 1E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Number of Participants Experiencing Dose Limiting Toxicities:1
Adverse reactions 0/3(All-couse mortality); 3/3(General disorders; Infections and infestations; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
Cohort4: CLL_dose level 1_ibrutinib
Administration route intravenous infusion
Dosage 1E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Number of Participants Experiencing Dose Limiting Toxicities:0
Adverse reactions 1/3(All-couse mortality); 1/3(Infections and infestations)

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