Back to results

Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma

Primary Purpose

B-cell Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

autologous anti-CD19 CAR T cells

About this trial

This is an interventional treatment trial for B-cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

CD19+ B cell lymphoma,verified by IHC or flow cytometry.
a prior history of at least two standard care of medication.
ineligible for allogeneic transplantation or relapsed after transplantation.
patients are 18 years older.
life expectancy > 3months.
ECOG ≤ 2.
satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.
women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
measurable tumors.

Exclusion Criteria:

using immunosuppressive drugs or systemic steroids within one week of enrollment.
active infection.
HIV positive.
active hepatitis B virus infection or hepatitis C virus infection.
breastfeeding or pregnant women.
patients refuse to practice birth control during study and one year post study.
patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
currently enrolled in other study.
patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

Sites / Locations

Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19 CAR T cells

Arm Description

A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Secondary Outcome Measures

Treatment response rate of anti-CD19 CAR T cell infusion

Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).

overall survival rate of patients treated with anti-CD19 CAR T cells

progression-free survival of patients treated with anti-CD19 CAR T cells

Full Information

NCT ID

NCT02842138

First Posted

July 13, 2016

Last Updated

February 21, 2019

Sponsor

Peking University

Collaborators

Marino Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02842138

Brief Title

Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma

Official Title

A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

Collaborators

Marino Biotechnology Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult 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

B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD19 CAR T cells

Arm Type

Experimental

Arm Description

A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.

Intervention Type

Biological

Intervention Name(s)

autologous anti-CD19 CAR T cells

Intervention Description

Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).

Primary Outcome Measure Information:

Title

Number of patients with adverse events

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Treatment response rate of anti-CD19 CAR T cell infusion

Description

Time Frame

4 weeks

Title

overall survival rate of patients treated with anti-CD19 CAR T cells

Time Frame

2 years

Title

progression-free survival of patients treated with anti-CD19 CAR T cells

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Persistence of CAR T cells in patients

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CD19+ B cell lymphoma,verified by IHC or flow cytometry. a prior history of at least two standard care of medication. ineligible for allogeneic transplantation or relapsed after transplantation. patients are 18 years older. life expectancy > 3months. ECOG ≤ 2. satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl . Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study. measurable tumors. Exclusion Criteria: using immunosuppressive drugs or systemic steroids within one week of enrollment. active infection. HIV positive. active hepatitis B virus infection or hepatitis C virus infection. breastfeeding or pregnant women. patients refuse to practice birth control during study and one year post study. patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study. currently enrolled in other study. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

31011207

Citation

Ying Z, Huang XF, Xiang X, Liu Y, Kang X, Song Y, Guo X, Liu H, Ding N, Zhang T, Duan P, Lin Y, Zheng W, Wang X, Lin N, Tu M, Xie Y, Zhang C, Liu W, Deng L, Gao S, Ping L, Wang X, Zhou N, Zhang J, Wang Y, Lin S, Mamuti M, Yu X, Fang L, Wang S, Song H, Wang G, Jones L, Zhu J, Chen SY. A safe and potent anti-CD19 CAR T cell therapy. Nat Med. 2019 Jun;25(6):947-953. doi: 10.1038/s41591-019-0421-7. Epub 2019 Apr 22.

Results Reference

derived

Learn more about this trial

Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma

We'll reach out to this number within 24 hrs