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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. Identifier: NCT02547948
Recruitment Status : Withdrawn
First Posted : September 14, 2015
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 14, 2015
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Tumor load [ Time Frame: up to 24 months ]
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 10, 2015)
B cell number and immunoglobulins [ Time Frame: up to 24 months ]
Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE CD19-targeting CAR T Cells for B Cell Lymphoma
Official Title  ICMJE CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B Cell Lymphoma
Intervention  ICMJE Biological: CD19-targeting CAR T Cells infusion
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
Study Arms  ICMJE
  • 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.
    Intervention: Biological: CD19-targeting CAR T Cells infusion
  • No Intervention: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2015)
Actual Study Completion Date  ICMJE August 15, 2016
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02547948
Other Study ID Numbers  ICMJE CD19-targeting CAR T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP