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CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03881761
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
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 1, 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 ]
adverse events rate
Change History Complete list of historical versions of study NCT03881761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2019)
  • objective response rate [ Time Frame: three months ]
    proportion of patients with complete response and partial response
  • survival time of CAR-T cells in vivo [ Time Frame: one year ]
    from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
  • progression-free survival [ Time Frame: one year ]
    the enrollment to the first time that disease progression is detected
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 CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Official Title  ICMJE Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
Brief Summary Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Detailed Description CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-Cell Lymphoma Stage I
  • Refractory
  • Relapsed
Intervention  ICMJE Biological: CD19/CD20 bispecific CAR-T cells
collecting 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 CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Study Arms  ICMJE Experimental: experimental arm
CAR-T cell group
Intervention: Biological: CD19/CD20 bispecific CAR-T cells
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2019)
50
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 lifetime>3 months
  • CD19/CD20 positive relapsed/refractory B cell lymphoma
  • KPS>70
  • at least one measurable lesion according to RECIST 1.1
  • enough function of hear, liver, kidney and bone marrow
  • no history of severe allergies
  • no other history of malignancy
  • no other diseases that conflict with this regimen
  • no serious mental illness
  • patient or family member sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe infectious or viral disease
  • Active B or C viral hepatitis
  • Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
  • participated in other clinical studies in the last 3 months, or have been treated with other gene products
  • Others not appropriate to participate in this study examined by the investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yongping Song, Dr. +86-37165587795 songyongping2018@126.com
Contact: Quanli Gao, Dr. +86-37165587483 gaoquanli2015@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881761
Other Study ID Numbers  ICMJE HenanCH CART 2-3
Has Data Monitoring Committee Not Provided
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 Not Provided
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 January 2019

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