Basic Information

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

GTO ID GTC0233
Trial ID NCT02349698
Disease B-Cell Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19 CAR-T cells
Generation2nd
PhasePhase1|Phase2
Recruitment statusRecruiting
TitleA Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Year2014
CountryChina
Company sponsorSouthwest Hospital, China
Other ID(s)TMMU-BTC-001
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted geneCD19 scFV; CD28; CD3zeta
Vector production methodT cells were produced by following a procedure of autologous T-cell culture and cell plate transfection, T-cell transfection and culture (days 0-8), and CAR-T cell harvesting by components of anti-CD3 monoclonal antibody OKT3 (Ortho Biotech), Retronectin: Takara, Japan, and Ficoll-Paque PLUS - GE Health Care Life Sciences.

Clinical Result

Cohort1: B cell-ALL
Administration route intravenous infusion
Dosage 2.83E6 cells/kg
Donor type Autologous
Pts 1
Age Child, Adult, Older_Adult
Lymph depletion Yes
Outcome 1/1(CR)
Adverse reactions 1/1(tension headache; vomiting; high fever)
References PMID: 34513679
Cohort2: ALL
Administration route intravenous infusion
Dosage 0.23E6~4.17E7 cells/kg
Donor type Autologous
Pts 10
Age Child, Adult, Older_Adult
Lymph depletion Yes
Outcome 10/10(CR)
Adverse reactions 4/10(cytokine release syndrome)
References PMID: 34513679

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