CD19-CART Treatment for ALL

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

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

Study Overview

• Status: Completed
• Conditions: Acute Leukemia
• Intervention / Treatment: Biological: CD19 CART

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • Shanghai Bioray Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD19-CART with a murine scFv; All enrolled patients in this arm will receive CD19-CART with a murine scFv.	Biological: CD19 CART; Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
EXPERIMENTAL: humanized CD19-CART; All enrolled patients in this arm will receive humanized CD19-CART.	Biological: CD19 CART; Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bioray Laboratories
• Collaborators: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): May 6, 2020
• Study Completion (ACTUAL): September 15, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHBYCL001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No