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Autologous CD19 CAR T Cells in Relapsed or Refractory 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: NCT02842138
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Marino Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Jun Zhu, Peking University

Brief Summary:
This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive B-cell lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Biological: autologous anti-CD19 CAR T cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma
Study Start Date : June 2016
Actual Primary Completion Date : February 28, 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CD19 CAR T cells
A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.
Biological: autologous anti-CD19 CAR T cells
Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).




Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Treatment response rate of anti-CD19 CAR T cell infusion [ Time Frame: 4 weeks ]
    Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).

  2. overall survival rate of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
  3. progression-free survival of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Persistence of CAR T cells in patients [ Time Frame: 2 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. CD19+ B cell lymphoma,verified by IHC or flow cytometry.
  2. a prior history of at least two standard care of medication.
  3. ineligible for allogeneic transplantation or relapsed after transplantation.
  4. patients are 18 years older.
  5. life expectancy > 3months.
  6. ECOG ≤ 2.
  7. satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
  8. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.
  9. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
  10. measurable tumors.

Exclusion Criteria:

  1. using immunosuppressive drugs or systemic steroids within one week of enrollment.
  2. active infection.
  3. HIV positive.
  4. active hepatitis B virus infection or hepatitis C virus infection.
  5. breastfeeding or pregnant women.
  6. patients refuse to practice birth control during study and one year post study.
  7. patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
  8. currently enrolled in other study.
  9. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

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): NCT02842138


Locations
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China
Peking University Cancer Hospital
Beijing, China, 100142
Sponsors and Collaborators
Peking University
Marino Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Jun Zhu, MD Beijing Cancer Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Zhu, Principal Investigator, Peking University
ClinicalTrials.gov Identifier: NCT02842138    
Other Study ID Numbers: 2016YJZ12
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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