CD19-CART Treatment for ALL

Phase 1

Completed

• Conditions: Acute Leukemia
• Interventions: Biological: CD19 CART

• Registration Number: NCT03232619
• Lead Sponsor: Bioray Laboratories

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2018-08-01
• Primary Completion: 2020-05-06
• Status Verified: 2020-09
• Study Completion: 2020-09-15
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD19-CART with a murine scFv	CD19 CART	All enrolled patients in this arm will receive CD19-CART with a murine scFv.
humanized CD19-CART	CD19 CART	All enrolled patients in this arm will receive humanized CD19-CART.

Primary Outcome Measures

Name	Time	Method
Radiological assessment	Month1 to Month12	Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

Secondary Outcome Measures

Name	Time	Method
The safety of CART immunotherapy	Day 1 to Week 4	After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity

Trial Locations

Locations (1)

Shanghai Bioray Inc.; 🇨🇳 Shanghai, Shanghai, China