CD19-CART Treatment for ALL

Bioray Laboratories4 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Leukemia

Interventions

CD19 CARTBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Bioray Inc.

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Radiological assessment

Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

Time frame: Month1 to Month12

Secondary Outcomes

The safety of CART immunotherapy

After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity

Time frame: Day 1 to Week 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.