Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia

February 6, 2021 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells

Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • 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: Yao Sun, M.D., Ph.D.
  • Phone Number: +86-010-6694-7402
  • Email: suny320@126.com

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • Department of Hematopoietic Stem Cell Transplantation
        • Contact:
          • Sun Yao, M.D., Ph.D.
          • Phone Number: +86-010-6694-7402
          • Email: suny320@126.com

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-65 years
  • Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
  • Refractory or relapsed B cell-acute lymphoblastic leukemia
  • No available curative treatment options (such as hematopoietic stem cell transplantation)
  • Stage III-IV disease
  • Creatinine < 2.5 mg/dl
  • Aspartate transaminase-alanine transaminase ratio < 3x normal
  • Bilirubin < 2.0 mg/dl
  • Karnofsky performance status >= 60
  • Expected survival time > 3 months
  • Adequate venous access for apheresis
  • Ability to understand and provide informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients requiring T cell immunosuppressive therapy
  • Active central nervous system leukemia
  • Any concurrent active malignancies
  • Patients with a history of a seizure disorder or cardiac disorder
  • Patients with human immunodeficiency virus, hepatitis B or C infection
  • Uncontrolled active 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T cells
Targeting CD19
Biological: CAR-T cells
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: 8 weeks
To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical responses to third generation CAR-T cells
Time Frame: 2 years
To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia
2 years

Collaborators and Investigators

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Liangding Hu, M.D., Affiliated Hospital to Academy of Military Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2016

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-CTC-CAR T

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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