CD19-CART Treatment for ALL

September 20, 2020 updated by: Bioray Laboratories

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Month1 to Month12
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
Time Frame: Day 1 to Week 4
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

This is where you will find people and organizations involved with this study.

Sponsor

Bioray Laboratories

Collaborators

Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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