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

Primary Purpose

Lymphomas Non-Hodgkin's B-Cell, Relapse

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CD19 CAR T cells

About this trial

This is an interventional treatment trial for Lymphomas Non-Hodgkin's B-Cell focused on measuring lymphoma, non-hodgkin, B-cell, CD19 CAR T cells, refractory, relapse

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Hematology & Blood Diseases Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19 CAR T cells

Arm Description

CD19 CAR T cells 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.

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Secondary Outcome Measures

Severity of the adverse events

Response rate

Progression-free survival(PFS)

Persistence of CAR T cells in vivo

Full Information

NCT ID

NCT03029338

First Posted

January 20, 2017

Last Updated

January 24, 2022

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Juventas Cell Therapy Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03029338

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 8, 2017 (Actual)

Primary Completion Date

May 22, 2019 (Actual)

Study Completion Date

June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Juventas Cell Therapy Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphomas Non-Hodgkin's B-Cell, Relapse

Keywords

lymphoma, non-hodgkin, B-cell, CD19 CAR T cells, refractory, relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD19 CAR T cells

Arm Type

Experimental

Arm Description

CD19 CAR T cells 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.

Intervention Type

Biological

Intervention Name(s)

CD19 CAR T cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Severity of the adverse events

Time Frame

2 years

Title

Response rate

Time Frame

12 months

Title

Progression-free survival(PFS)

Time Frame

2 years

Title

Persistence of CAR T cells in vivo

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dehui Zou, Dr.

Organizational Affiliation

Institute of Hematology & Blood Diseases Hospital, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Hematology & Blood Diseases Hospital

City

Tianjin

ZIP/Postal Code

300020

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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