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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03671460
• Other study ID #: TianjinMycure-LDP-CD19 CAR-T
• Status: Recruiting
• Phase: Phase 1
• Start date: September 7, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2018
• Source: Tianjin Mycure Medical Technology Co., Ltd
• Contact: Chaoting Zhang, PhD
• Phone: 86-010-88196768
• Email: zhangchaoting1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CD19 CAR-T cells
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-? lentiviral vector, expanded in vitro for future administration.

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Langfang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Mycure Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adverse events	Percentage of participants with adverse events	6 months
Secondary	complete remission rate	The percentage of participants who achieved complete remission (CR) over all participants (CRR).	6 months
Secondary	objective remission rate	The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).	6 months