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Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin 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: NCT04012892
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Shenzhen University
Shenzhen University General Hospital
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital

Brief Summary:
This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma

Condition or disease Intervention/treatment Phase
Relapsed Non-Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Combination Product: CD19 CART Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: study group
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
Combination Product: CD19 CART
CD19 CART




Primary Outcome Measures :
  1. recovery rate of patients being treated with CD19CAR-T [ Time Frame: 6 months ]
    the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
  2. Age 18 to 65 years old, both male and female;
  3. Is expected to survive more than 12 weeks;
  4. Physical condition is good: 0-1 score ECOG score;
  5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  3. Pregnancy and lactation women;
  4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  5. The Investigator believe the patients should not participate in this experiment.

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): NCT04012892


Contacts
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Contact: Lixing Wang, MD 86-0755-21839178 wanglixin1991@sohu.com

Locations
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China
Shenzhen University General Hospital Recruiting
Shenzhen, China, 518000
Contact: Lixing Wang, M.D.    86-0755-21839178    wanglixin1991@sohu.com   
Principal Investigator: Li Yu, M.D. Ph.D.         
Principal Investigator: Lixing Wang, M.D         
Sponsors and Collaborators
Chinese PLA General Hospital
Shenzhen University
Shenzhen University General Hospital

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Responsible Party: Li Yu, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04012892     History of Changes
Other Study ID Numbers: HEM-NHL001-CART
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases