CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

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

Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Study Type

Interventional

Enrollment (Estimated)

20

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

Study Locations

  • China
      • Suzhou, China
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

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+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:
  • 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: Cohort 1
Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
Biological: CART-19/22
Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19/22 cells/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of 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

Collaborators

The First Affiliated Hospital of Soochow University

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)

September 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 28, 2018

First Submitted That Met QC Criteria

July 28, 2018

First Posted (Actual)

August 3, 2018

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UnicarTherapy201807

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.

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