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CD19-targeting CAR T Cells for B Cell 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547948
Recruitment Status : Withdrawn
First Posted : September 14, 2015
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Biological: CD19-targeting CAR T Cells infusion Phase 1 Phase 2

Detailed Description:
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : August 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CAR T cells
In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.
Biological: CD19-targeting CAR T Cells infusion
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma

No Intervention: No Intervention



Primary Outcome Measures :
  1. CAR T cell persistence [ Time Frame: up to 24 months ]
    Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood


Secondary Outcome Measures :
  1. Tumor load [ Time Frame: up to 24 months ]
    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis


Other Outcome Measures:
  1. B cell number and immunoglobulins [ Time Frame: up to 24 months ]
    Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed or refractory CD19+ B-cell lymphoma.
  2. Measurable disease.
  3. Performance status ECOG 0-2.
  4. Age:18-80.
  5. Fertile females/males must consent to use contraceptives during participation of the trial.
  6. Signed informed consent

Exclusion Criteria:

  1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
  2. Patients with primary CNS lymphoma.
  3. Known human immunodeficiency virus (HIV) infection.
  4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
  5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
  6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
  7. Patients that do not consent to that tissue and blood samples are stored in a biobank.
  8. Pregnancy.

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): NCT02547948


Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02547948    
Other Study ID Numbers: CD19-targeting CAR T
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Fuda Cancer Hospital, Guangzhou:
CD19
CAR T Cells
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin