Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349698
Recruitment Status : Recruiting
First Posted : January 29, 2015
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shiqi Li, Southwest Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Chimeric Antigen Receptor Modified T cells Targeting CD19 Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Study Start Date : December 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells [ Time Frame: 12 weeks ]
  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349698


Contacts
Layout table for location contacts
Contact: Cheng Qian, MD,PhD 0086-023-68765461 cqian3184@163.com
Contact: Zhi Yang, PhD 0086-13206140093 Lystch@outlook.com

Locations
Layout table for location information
China, Chongqing
Southwest Hospital of Third Millitary Medical University Recruiting
Chongqing, Chongqing, China, 400000
Contact: Cheng Qian, PhD    008615086883400    cqian3184@163.com   
Contact: Zhi Yang, PhD    008613206140093      
Principal Investigator: Cheng Qian, PhD         
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Layout table for investigator information
Study Chair: Cheng Qian, MD, PhD Biotherapy Center of Southwest Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shiqi Li, Researcher of Biotherpy Center, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02349698    
Other Study ID Numbers: TMMU-BTC-001
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shiqi Li, Southwest Hospital, China:
CAR T
Leukemia
Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases