Basic Information

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

GTO ID GTC0326
Trial ID NCT02842138
Disease B-Cell Lymphoma
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19-BBz(86) CAR-T cells
Generation2nd
PhasePhase1
Recruitment statusUnknown
TitleAutologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma
Year2016
CountryChina
Company sponsorPeking University
Other ID(s)2016YJZ12
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted gene86-amino-acid fragment from human CD8α, comprising a longer extracellular-domain fragment (55 amino acids versus 45 amino acids in the CD19-BBz(71) prototype) and a longer intracellular sequence (7 amino acids versus 3 amino acids; truncated, nonfunctional epidermal growth factor receptor (tEGFR)
Vector production methodPBMCs were collected from patients by leukapheresis. PBMCs were isolated and purified from leukapheresis products by Ficoll-Paque density-gradient centrifugation and were then seeded into flasks that had been coated with anti-CD3/anti-CD28 antibodies. PBMCs were cultured in X-VIVO 15 medium supplemented with IL-2. Two days after initial T cell activation, T cells were transduced with a lentivirus encoding CD19-BBz(86) CAR. Cells were expanded for an additional 11-13 d.
Additional featuretEGFR

Clinical Result

Cohort1: dose level 1
Administration route None
Dosage 3~6E6 cells
Donor type Autologous
Pts 6
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/6(CR); 2/6(PR); 1/6(SD); 2/6(PD)
Adverse reactions no any CAR-T-related severe events
References PMID: 31011207
Cohort2: dose level 2
Administration route None
Dosage 6~19E7 cells
Donor type Autologous
Pts 8
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 4/8(PR); 1/8(SD); 3/8(PD)
Adverse reactions no any CAR-T-related severe events
References PMID: 31011207
Cohort3: dose level 3
Administration route None
Dosage 2~4E8 cells
Donor type Autologous
Pts 11
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 6/11(CR); 2/11(PR); 3/11(PD)
Adverse reactions no any CAR-T-related severe events
References PMID: 31011207

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