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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03232619
Other study ID # SHBYCL001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2018
Est. completion date September 15, 2020

Study information

Verified date September 2020
Source Shanghai Bioray Laboratory Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.


Description:

Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date September 15, 2020
Est. primary completion date May 6, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 70 Years
Eligibility Inclusion Criteria:

1. previously identified as CD19+ ALL.

2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.

3. Expected survival >12W.

4. Creatinine < 2.5 mg/dl.

5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal

6. Bilirubin <2.0 mg/dl

7. Voluntary informed consent is given.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Uncontrolled active infection.

3. Active hepatitis B or hepatitis C infection.

4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

5. Previously treatment with any gene therapy products.

6. Any uncontrolled active medical disorder that would preclude participation as outlined.

7. HIV infection.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD19 CART
Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.

Locations

Country Name City State
China Shanghai Bioray Inc. Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Bioray Laboratory Inc. Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological assessment Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan. Month1 to Month12
Secondary The safety of CART immunotherapy After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity Day 1 to Week 4
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