CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

Relapse Clinical Trial

Official title:

CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029338
• Other study ID #: XH-CD19CART-002
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2017
• Est. completion date: June 22, 2021

Study information

• Verified date: January 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.

Description:

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 22, 2021
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

• Adequate end organ function as defined by: Total bilirubin = 1.5 x upper limit of normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN; Creatinine = 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of = 40ml/min.

• Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.

• Patients should sign informed consent form.

Exclusion Criteria:

• Patients with central nervous system involvement by lymphoma.

• Prior chemotherapy within 2 weeks before enrollment with the following exceptions:

steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.

• Prior allogeneic hematopoietic stem cell transplant (HSCT) = 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have= grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.

• Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).

• Major surgery within 4 weeks before enrollment.

• Impaired cardiac function:Ejection fraction =45 % on MUGA scan. QTc interval > 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).

• Administration of live vaccine = 4 weeks before enrollment.

• Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphomas Non-Hodgkin's B-Cell
• Recurrence
• Relapse

Intervention

Biological:
• CD19 CAR T cells
CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCR?:4-1BB.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital	Juventas Cell Therapy Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		2 years
Secondary	Severity of the adverse events		2 years
Secondary	Response rate		12 months
Secondary	Progression-free survival(PFS)		2 years
Secondary	Persistence of CAR T cells in vivo		2 years