CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

NCT ID: NCT03671460

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2021-01-01

Brief Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Detailed Description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. 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 R/R B-ALL.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD19-CAR-T Cells

Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.

Group Type: EXPERIMENTAL

CD19 CAR-T cells

Intervention Type: BIOLOGICAL

T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

Interventions

CD19 CAR-T cells

T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. More than 1 year;

2. CD19 positive B-cell acute lymphoblastic leukemia;

3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.

4. Expected to survive for more than 3 months;

5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. Recent or current use of glucocorticoid or other immunosuppressor;

2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;

3. Has a graft-versus-host response and requires the use of immunosuppressants；

4. Drug uncontrollable central nervous system leukemia；

5. Pregnant or lactating female；

6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year；

7. A history of other malignant tumors;

8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Mycure Medical Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peihua Lu, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Hebei Yanda Ludaopei Hospital

Locations

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chaoting Zhang, PhD

Role: CONTACT

zhangchaoting1@163.com

86-010-88196768

Facility Contacts

Peihua Lu, MD, PhD

Role: primary

peihua_lu@126.com

18611636172

Other Identifiers

TianjinMycure-LDP-CD19 CAR-T

Identifier Type: -

Identifier Source: org_study_id