Basic Information

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

GTO ID GTC0299
Trial ID NCT02706405
Disease Large B-Cell Lymphoma
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment JCAR014
Co-treatment Durvalumab
Generation2nd
PhasePhase1
Recruitment statusTerminated
TitleJCAR014 and Durvalumab in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Year2016
CountryUnited States
Company sponsorFred Hutchinson Cancer Center
Other ID(s)9457|NCI-2015-02286|9457|P30CA015704|R01CA136551|RG6616001
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted geneCD19 scFV; 4-1BB; CD3zeta
Additional featureEGFRt

Clinical Result

Cohort1: 750 mg Durvalumab on day 7
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 5
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/4(CR); 1/4(PR)
Adverse reactions 3/5(All-cause mortality); 4/5(Blood and lymphatic system disorders; Cardiac disorders; General disorders; Immune system disorders; Infections and infestations; Metabolism and nutrition disorders; Nervous system disorders; Vascular disorders)
References DOI: 10.1182/blood-2022-168185
Cohort2: 225 mg Durvalumab on day 21
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/3(CR); 0/3(PR)
Adverse reactions 2/3(All-cause mortality); 3/3(Cardiac disorders; Gastrointestinal disorders; General disorders; Immune system disorders; )
References DOI: 10.1182/blood-2022-168185
Cohort3: 750 mg Durvalumab on day 21
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/3(CR); 1/3(PR)
Adverse reactions 2/3(Immune system disorders; Infections and infestations; Renal and urinary disorders)
References DOI: 10.1182/blood-2022-168185
Cohort4: 7.5 mg Durvalumab on day -1
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 0/1(CR); 0/1(PR)
Adverse reactions 1/1(All-cause mortality); 1/1(General disorders)
References DOI: 10.1182/blood-2022-168185
Cohort5: 22.5 mg Durvalumab on day -1
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/1(CR)
Adverse reactions no any CAR-T-related severe events
References DOI: 10.1182/blood-2022-168185
Cohort6: 75 mg Durvalumab on day -1
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/3(CR); 0/3(PR)
Adverse reactions 2/3(Immune system disorders; Infections and infestations; )
References DOI: 10.1182/blood-2022-168185
Cohort7: 225 mg Durvalumab on day -1
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 6
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/6(CR); 0/6(PR)
Adverse reactions 3/6(All-cause mortality); 4/6(General disorders; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Neoplasms benign, malignant and unspecified; Respiratory, thoracic and mediastinal disorders)
References DOI: 10.1182/blood-2022-168185
Cohort8: 750 mg Durvalumab on day -1
Administration route intravenous infusion
Dosage <= 2E6 cells/kg
Donor type Autologous
Pts 7
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/7(CR); 1/7(PR)
Adverse reactions 4/7(All-cause mortality); 4/7(Blood and lymphatic system disorders; General disorders; Immune system disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)
References DOI: 10.1182/blood-2022-168185

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