CD19-CART Treatment for ALL

Acute Leukemia Clinical Trial

Official title:

Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232619
• Other study ID #: SHBYCL001
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Acute Leukemia

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