A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

June 23, 2019 updated by: Shiqi Li, Southwest Hospital, China

A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

45

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: Cheng Qian, MD，PhD
  • Phone Number: 0086-023-68765461
  • Email: cqian3184@163.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Southwest Hospital of Third Millitary Medical University

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

4 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 4 years to 75 years.
  5. Disease progresses but reserves reaction to recent treatments.
  6. Patients who have failed at least one line of a standard treatment.
  7. No serious mental disorder.
  8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
  9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  10. No other tumors.
  11. Patients volunteer to participate in the research.

Exclusion Criteria:

  1. HIV affected.
  2. Patients are allergic to cytokines.
  3. Central nervous system leukemia within 28 days.
  4. Uncontrolled active infection.
  5. Acute or chronic GVHD.
  6. Treated with T cell inhibitor.
  7. Pregnancy and nursing females.
  8. Other situations we think improper for the research.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Other: Chronic Lymphcytic Leukemia
Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Other: Non-Hodgkin Lymphoma
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events of each patient.
Time Frame: 3 years
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival time of Anti-CD19 CAR T cells in vivo.
Time Frame: 3 years
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
3 years
Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells
Time Frame: 12 weeks
12 weeks
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame: 4 weeks
To confirm the maximum tolerated dose of CD19 targeted CAR T cells.
4 weeks

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 25, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 23, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMMU-BTC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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