Basic Information

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

GTO ID GTC0146
Trial ID NCT01593696
Disease Acute Lymphoblastic Leukemia | B-Cell Lymphoma | Large B-Cell Lymphoma | Non-Hodgkin's Lymphoma | Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19 CAR-T cells
Generation2nd
PhasePhase1
Recruitment statusCompleted
TitleAnti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma
Year2012
CountryUnited States
Company sponsorNational Cancer Institute (NCI)
Other ID(s)120112|12-C-0112

Clinical Result

Cohort1: Phase 1_dose level 1
Administration route None
Dosage 1E6 cells/kg (±20%)
Pts 16
Age Child, Adult
Lymph depletion Yes
Outcome 10/16(CR, 28 days); 10/16(Grade 4 Cytokine Release Syndrome)
Adverse reactions 10/16(all-cause mortality); 6/16(Cardiac disorders; General disorders; Immune system disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 35148417
Cohort2: Phase 1_dose level 2
Administration route None
Dosage 3E6 cells/kg (±20%)
Pts 5
Age Child, Adult
Lymph depletion Yes
Outcome 4/5(CR, 28 days); 4/5(Grade 4 Cytokine Release Syndrome)
Adverse reactions 3/5(all-cause mortality); 2/5(Immune system disorders; Nervous system disorders)
References PMID: 35148417
Cohort3: Phase 2_dose level 1_standard lymphodepleting
Administration route None
Dosage 1E6 cells/kg (±20%)
Pts 16
Age Child, Adult
Lymph depletion Yes
Outcome 11/15(CR, 28 days); 11/15(Grade 4 Cytokine Release Syndrome)
Adverse reactions 5/16(all-cause mortality); 1/16(Cardiac disorders; General disorders; Immune system disorders; Musculoskeletal and connective tissue disorders; Nervous system disorders; Vascular disorders)
References PMID: 35148417
Cohort4: Phase 2_dose level 1_intensive lymphodepleting
Administration route None
Dosage 1E6 cells/kg (±20%)
Pts 16
Age Child, Adult
Lymph depletion Yes
Outcome 6/16(CR, 28 days); 6/16(Grade 4 Cytokine Release Syndrome)
Adverse reactions 11/16(all-cause mortality); 5/16(Cardiac disorders; General disorders; Immune system disorders; Musculoskeletal and connective tissue disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 35148417

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