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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04008251
Other study ID # CART-huCD19-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 27, 2019
Est. completion date December 31, 2022

Study information

Verified date July 2019
Source Wuhan Sian Medical Technology Co., Ltd
Contact Yu Hu, M.D., Ph.D
Phone 86-13986183871
Email dr_huyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.


Description:

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility Inclusion Criteria:

1. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-HSCT/allo-HSCT; or patients voluntarily choose CD19 CAR-T cells as a first treatment;

2. B cell hematological malignancies include the following three categories:

A. B-cell acute lymphocytic leukemia (B-ALL);

B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL);

C. Aggressive B-cell lymphoma (DLBCL, BL, MCL);

3. Aged from 14 to 70 years old;

4. Expected survival time > 6 months;

5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;

6. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

Exclusion Criteria:

1. With a history of epilepsy or other central nervous system diseases;

2. Having graft-versus-host reaction, requires the use of immunosuppressants;

3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);

4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);

5. Not curable active infection;

6. Patients with active hepatitis B or hepatitis C virus infection;

7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);

8. Using product of gene therapy before;

9. Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L);

10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;

11. Patients with HIV-infection;

12. Any situation that may increase the risk of patients or interfere with test results.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Second generation humanized CAR-T cells
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

Locations

Country Name City State
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (5)

Lead Sponsor Collaborator
Wuhan Sian Medical Technology Co., Ltd Jingzhou Central Hospital, People Hospital Of Yichang, Wuhan Union Hospital, China, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) 5 years
Secondary One-month remission rate Response of B-ALL to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015). 1 month
Secondary Overall survival OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored). 5 years
Secondary Event-free survival EFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored). 5 years
Secondary Relapse-free survival RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored). 5 years
Secondary Rate of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells In vivo (bone marrow and peripheral blood) rate of CAR-T cells were determined by means of flow cytometry. 5 years
Secondary Quantity of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry. 5 years
Secondary Quantity of anti-CD19 CAR copies in bone marrow cells and peripheral blood cells In vivo (bone marrow and peripheral blood) quantity of anti-CD19 CAR copies were determined by means of qPCR. 5 years
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