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

Phase 1

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: CD19 CAR-T cells

• Registration Number: NCT03671460
• Lead Sponsor: Tianjin Mycure Medical Technology Co., Ltd

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.

Study Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-07
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-13
• Last Update Submitted: 2018-09-13
• Study First Posted: 2018-09-14
• Last Update Posted: 2018-09-14
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of adverse events	6 months	Percentage of participants with adverse events

Secondary Outcome Measures

Name	Time	Method
complete remission rate	6 months	The percentage of participants who achieved complete remission (CR) over all participants (CRR).
objective remission rate	6 months	The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).

Trial Locations

Locations (1)

Hebei Yanda Ludaopei Hospital; 🇨🇳 Langfang, Hebei, China