Back to results

The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

Primary Purpose

B-cell Acute Lymphoblastic Leukemia

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

Fludarabine

CART-19 cells

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

4 years to 70 years, expected survival > 3 months
CD19 positive B-cell acute lymphoblastic leukemia
Karnofsky Performance Status (KPS) >70
Relapsed after allogeneic or autologous stem cell transplantation (SCT);
Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
No serious allergic constitution
No other serous diseases that conflicts with the clinical program
No other cancer history
No serious mental disorder
Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
Uncontrolled active infection, HIV infection, syphilis serology reaction positive
Active hepatitis B or hepatitis C infection
Recent or current use of glucocorticoid or other immunosuppressor
With severe cardiac, liver, renal insufficiency, diabetes and other diseases
Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN
Participate in other clinical research in the past three months; previously treatment with any gene therapy products
Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Sites / Locations

Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CART-19

Arm Description

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.

Outcomes

Primary Outcome Measures

safety as assessed by the occurrence of study related adverse events.

monitor the occurrence of study related adverse events.

Secondary Outcome Measures

efficacy

anti-tumor activity of CART-19 cells will be determined in a follow-on study

duration of CART-19

Determine duration of in vivo survival of CART-19 cells.

Full Information

NCT ID

NCT02924753

First Posted

September 29, 2016

Last Updated

December 28, 2017

Sponsor

Henan Cancer Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02924753

Brief Title

The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

Official Title

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 18, 2016 (Actual)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henan Cancer Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Detailed Description

Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects. Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

6. Conditions and Keywords

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

B-cell Acute Lymphoblastic Leukemia

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CART-19

Arm Type

Experimental

Arm Description

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).

Intervention Type

Biological

Intervention Name(s)

CART-19 cells

Other Intervention Name(s)

CD19 specific Chimeric Antigen Receptor T-cells

Intervention Description

CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Primary Outcome Measure Information:

Title

safety as assessed by the occurrence of study related adverse events.

Description

monitor the occurrence of study related adverse events.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

efficacy

Description

anti-tumor activity of CART-19 cells will be determined in a follow-on study

Time Frame

2 years

Title

duration of CART-19

Description

Determine duration of in vivo survival of CART-19 cells.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 4 years to 70 years, expected survival > 3 months CD19 positive B-cell acute lymphoblastic leukemia Karnofsky Performance Status (KPS) >70 Relapsed after allogeneic or autologous stem cell transplantation (SCT); Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L） No serious allergic constitution No other serous diseases that conflicts with the clinical program No other cancer history No serious mental disorder Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) Uncontrolled active infection, HIV infection, syphilis serology reaction positive Active hepatitis B or hepatitis C infection Recent or current use of glucocorticoid or other immunosuppressor With severe cardiac, liver, renal insufficiency, diabetes and other diseases Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN Participate in other clinical research in the past three months; previously treatment with any gene therapy products Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongping Song

ph200811@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongping Song

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongping Song

ph200811@163.com

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

We'll reach out to this number within 24 hrs