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Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

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. Identifier: NCT03881774
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 21, 2019
Henan Hualong Biotechnology Company
Information provided by (Responsible Party):
Henan Cancer Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE February 27, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
occurrence of study related adverse events [ Time Frame: one year ]
safety of CAR-T cells
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2019)
safety [ Time Frame: one year ]
the rate of adverse events
Change History Complete list of historical versions of study NCT03881774 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2019)
  • objective response rate [ Time Frame: three months ]
    the proportion of patients with CR or PR
  • progression-free survival [ Time Frame: one year ]
    from the date of enrollment to the first date of progression detected
  • overall survival [ Time Frame: one year ]
    from the date of enrollment to the date of death
  • copy number of CAR-T [ Time Frame: six months ]
    copy number of CAR-T in blood and bone marrow
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Official Title  ICMJE Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
Brief Summary Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Detailed Description CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
CAR-T cell group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory
  • Relapsed
  • B Cell Lymphoma
  • B Cell Leukemia
Intervention  ICMJE Biological: CAR-T cells
collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg
Other Name: cord blood derived CAR-T cells
Study Arms  ICMJE Experimental: experimental arm
cord blood derived CAR T cells group
Intervention: Biological: CAR-T cells
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • expected lifespan >3 months
  • patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
  • KPS >70
  • for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
  • enough function of heart, liver, kidney and bone marrow
  • no history of severy allergy
  • no other serious diseases that conflict with this plan
  • no other history of malignancy
  • no serious mental illness
  • patients and their families members agree to participate in this clinical study and sign the Informed Consent Form

Exclusion Criteria:

  • pregnant or lactating women
  • vevere infectious or viral diseases
  • active hepatitis B or C viral hepatitis
  • Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
  • participated in other clinical studies in the past 3 months or who have been treated with other gene products;
  • others that other investigators consider not suitable for this clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yongping Song, Dr. +86-37165587795
Contact: Quanli Gao, Dr. +86-37165587483
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03881774
Other Study ID Numbers  ICMJE HenanCH CART 2-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Henan Hualong Biotechnology Company
Investigators  ICMJE
Study Chair: Yongping Song, Dr. Henan Cancer Hospital
PRS Account Henan Cancer Hospital
Verification Date March 2019

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