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Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02842138
Recruitment Status : Unknown
Verified February 2019 by Jun Zhu, Peking University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE July 13, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
Number of patients with adverse events [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • 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).
  • overall survival rate of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
  • progression-free survival of patients treated with anti-CD19 CAR T cells [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2016)
Persistence of CAR T cells in patients [ Time Frame: 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Lymphoma
Intervention  ICMJE 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%).
Study Arms  ICMJE 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.
Intervention: Biological: autologous anti-CD19 CAR T cells
Publications * Ying Z, Huang XF, Xiang X, Liu Y, Kang X, Song Y, Guo X, Liu H, Ding N, Zhang T, Duan P, Lin Y, Zheng W, Wang X, Lin N, Tu M, Xie Y, Zhang C, Liu W, Deng L, Gao S, Ping L, Wang X, Zhou N, Zhang J, Wang Y, Lin S, Mamuti M, Yu X, Fang L, Wang S, Song H, Wang G, Jones L, Zhu J, Chen SY. A safe and potent anti-CD19 CAR T cell therapy. Nat Med. 2019 Jun;25(6):947-953. doi: 10.1038/s41591-019-0421-7. Epub 2019 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 23, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2016)
20
Estimated Study Completion Date  ICMJE August 2019
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02842138
Other Study ID Numbers  ICMJE 2016YJZ12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Jun Zhu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Marino Biotechnology Co., Ltd.
Investigators  ICMJE
Principal Investigator: Jun Zhu, MD Beijing Cancer Hospital
PRS Account Peking University
Verification Date February 2019

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