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CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Primary Purpose

Leukemia, B-cell

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CART-19/22

About this trial

This is an interventional treatment trial for Leukemia, B-cell focused on measuring CD19, CD22

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:
Age 6-65 years.
Left ventricular ejection fractions≥ 0.5 by echocardiography.
Creatinine < 1.6 mg/dL.
Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
Bilirubin <2.0 mg/dL.
Karnofsky performance status ≥ 60
Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

Pregnant or lactating women.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
HIV infection.
Patients with history of seizure
Active central nervous system leukemia

Sites / Locations

The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1

Arm Description

Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Outcomes

Primary Outcome Measures

Number of Adverse Events

Adverse events are evaluated with CTCAE V4.03

Secondary Outcome Measures

Full Information

NCT ID

NCT03614858

First Posted

July 28, 2018

Last Updated

May 18, 2022

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Collaborators

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT03614858

Brief Title

CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Official Title

Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Collaborators

The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Detailed Description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

6. Conditions and Keywords

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

Leukemia, B-cell

Keywords

CD19, CD22

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

CART-19/22

Intervention Description

Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19/22 cells/kg).

Primary Outcome Measure Information:

Title

Number of Adverse Events

Description

Adverse events are evaluated with CTCAE V4.03

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows: Age 6-65 years. Left ventricular ejection fractions≥ 0.5 by echocardiography. Creatinine < 1.6 mg/dL. Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal. Bilirubin <2.0 mg/dL. Karnofsky performance status ≥ 60 Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: Pregnant or lactating women. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Class III/IV cardiovascular disability according to the New York Heart Association Classification. HIV infection. Patients with history of seizure Active central nervous system leukemia

Central Contact Person:

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

Xiaowen Tang, Ph.D.

Phone

(0086)51267781856

tangxiaowen@suda.edu.cn

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

Lei Yu, Ph.D.

Phone

8613818629089

ylyh188@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, Ph.D.

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Soochow University

City

Suzhou

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, Ph.D

Phone

(0086)51267781856

tangxiaowen@suda.edu.cn

12. IPD Sharing Statement

Learn more about this trial

CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

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