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Completed

NCT Number: NCT03232619

CD19-CART Treatment for ALL

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

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Key information

Conditions

Acute Leukemia

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Bioray Inc.

Shanghai, Shanghai Municipality, 200240, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previously identified as CD19+ ALL.
  • ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
  • Expected survival >12W.
  • Creatinine < 2.5 mg/dl.
  • Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
  • Bilirubin <2.0 mg/dl
  • Voluntary informed consent is given.

Exclusion criteria

  • Pregnant or lactating women.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Previously treatment with any gene therapy products.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.

Treatment and study plan

CD19 CART

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bioray Laboratories

Industry

Collaborators

  • Second Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2017
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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