CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

November 27, 2023 updated by: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

Study Type

Interventional

Enrollment (Estimated)

15

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 Contact

Study Contact Backup

  • Name: Lei Yu, Ph.D.
  • Phone Number: (0086)13818629089
  • Email: ylyh188@163.com

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Xiaowen Tang, Ph.D.

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 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia
  • Age 6-65 years.
  • Left ventricular ejection fractions≥ 0.5 by echocardiography.
  • Creatinine < 1.6 mg/dL.
  • Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
  • Bilirubin <2.0 mg/dL.
  • Karnofsky performance status ≥ 60
  • Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

  • Pregnant or lactating women.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification.
  • HIV infection.
  • Patients with history of seizure
  • Active central nervous system leukemia

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD19 positive relapsed or refractory acute myeloid leukemia
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Biological: CART-19
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 months
Adverse events are evaluated with CTCAE V4.03
12 months

Collaborators and Investigators

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

Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Investigators

  • Principal Investigator: Xiaowen Tang, Ph.D., The First Affiliated Hospital of Soochow 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)

October 18, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UnicarTherapy20190308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on CART-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe