Basic Information

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

GTO ID GTC0175
Trial ID NCT01865617
Disease Acute Lymphoblastic Leukemia | Chronic Lymphocytic Leukemia | Non-Hodgkin's Lymphoma
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19 CAR-T cells
Generation2nd
PhasePhase1|Phase2
Recruitment statusCompleted
TitleLaboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia
Year2013
CountryUnited States
Company sponsorFred Hutchinson Cancer Center
Other ID(s)2639.00|NCI-2013-00073|2639|RG9213011|P50CA107399|R01CA136551
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted geneCD19 CAR; a truncated cell surface human epidermal growth factor receptor (EGFRt); CD19-specific scFv; CD28 transmembrane domain; 4-1BB costimulatory domain; CD3ζ signaling domain
Vector production methodThe selected CD4+ and CD8+ T cells were transduced with a lentiviral vector that encoded the CD19 CAR and a truncated cell surface human epidermal growth factor receptor (EGFRt), which enabled identification of transduced cells by flow cytometry using the anti-EGFR monoclonal antibody, cetuximab.
Additional featureEGFRt

Clinical Result

Cohort1: dose level 1_ALL (High Tumor Burden)
Administration route intravenous infusion
Dosage 2E5 cells/kg
Donor type Autologous
Pts 39
Age Adult, Older_Adult
Outcome 32/39(OR)
Adverse reactions 27/39(All-cause mortality); 39/39(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Immune system disorders; Infections and infestations; Investigations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort2: dose level 2_ALL (High Tumor Burden)
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 5
Age Adult, Older_Adult
Outcome 5/5(OR)
Adverse reactions 3/5(All-cause mortality); 5/5(Blood and lymphatic system disorders; General disorders; Immune system disorders; Infections and infestations; Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort3: dose level 3_ALL (High Tumor Burden)
Administration route intravenous infusion
Dosage 2E7 cells/kg
Donor type Autologous
Pts 2
Age Adult, Older_Adult
Outcome 1/2(OR)
Adverse reactions 1/2(All-cause mortality); 2/2(Blood and lymphatic system disorders; Cardiac disorders; General disorders; Immune system disorders; Metabolism and nutrition disorders; Nervous system disorders; Psychiatric disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort4: dose level 1_ALL (Low Tumor Burden)
Administration route intravenous infusion
Dosage 2E5 cells/kg
Donor type Autologous
Pts 1
Age Adult, Older_Adult
Outcome 1/1(OR)
Adverse reactions 1/1(All-cause mortality)
References PMID: 27605551
Cohort5: dose level 2_ALL (Low Tumor Burden)
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 18
Age Adult, Older_Adult
Outcome 18/18(OR)
Adverse reactions 5/18(All-cause mortality); 14/18(Blood and lymphatic system disorders; General disorders; Immune system disorders; Infections and infestations; Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort6: dose level 1_CLL
Administration route intravenous infusion
Dosage 2E5 cells/kg
Donor type Autologous
Pts 5
Age Adult, Older_Adult
Outcome 4/5(OR)
Adverse reactions 1/5(All-cause mortality); 5/5(Blood and lymphatic system disorders; Gastrointestinal disorders; Immune system disorders; Infections and infestations; )
References PMID: 27605551
Cohort7: dose level 2_CLL
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 22
Age Adult, Older_Adult
Outcome 16/22(OR)
Adverse reactions 11/22(All-cause mortality); 22/22(Blood and lymphatic system disorders; Cardiac disorders; General disorders; Immune system disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort8: dose level 3_CLL
Administration route intravenous infusion
Dosage 2E7 cells/kg
Donor type Autologous
Pts 1
Age Adult, Older_Adult
Outcome 1/1(OR)
Adverse reactions 1/1(All-cause mortality); 1/1(Blood and lymphatic system disorders; Immune system disorders; Infections and infestations; Vascular disorders)
References PMID: 27605551
Cohort9: dose level 2_CLL_Ibrutinib
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 20
Age Adult, Older_Adult
Outcome 12/20(OR)
Adverse reactions 11/20(All-cause mortality); 20/20(Blood and lymphatic system disorders; Gastrointestinal disorders; General disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Psychiatric disorders; )
References PMID: 27605551
Cohort10: dose level 1_NHL
Administration route intravenous infusion
Dosage 2E5 cells/kg
Donor type Autologous
Pts 5
Age Adult, Older_Adult
Outcome 2/5(OR)
Adverse reactions 3/5(All-cause mortality); 5/5(Blood and lymphatic system disorders; Cardiac disorders; Immune system disorders; Infections and infestations; Respiratory, thoracic and mediastinal disorders)
References PMID: 27605551
Cohort11: dose level 2_NHL
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 49
Age Adult, Older_Adult
Outcome 28/49(OR)
Adverse reactions 32/49(All-cause mortality); 49/49(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551
Cohort12: dose level 3_NHL
Administration route intravenous infusion
Dosage 2E7 cells/kg
Donor type Autologous
Pts 10
Age Adult, Older_Adult
Outcome 4/10(OR)
Adverse reactions 6/10(All-cause mortality); 7/10(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Nervous system disorders; Vascular disorders)
References PMID: 27605551
Cohort13: dose level 2_NHL(Dose Dense)
Administration route intravenous infusion
Dosage 2E6 cells/kg
Donor type Autologous
Pts 20
Age Adult, Older_Adult
Outcome 10/20(OR)
Adverse reactions 13/20(All-cause mortality); 20/20(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Immune system disorders; Infections and infestations; Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 27605551

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