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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

Brief Summary:
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma

Condition or disease Intervention/treatment Phase
B-Cell Lymphoma Stage I Refractory Relapsed Biological: CD19/CD20 bispecific CAR-T cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: experimental arm
CAR-T cell group
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




Primary Outcome Measures :
  1. occurrence of study related adverse events [ Time Frame: one year ]
    safety of CAR-T cells


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: three months ]
    proportion of patients with complete response and partial response

  2. 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

  3. progression-free survival [ Time Frame: one year ]
    the enrollment to the first time that disease progression is detected



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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03881761


Contacts
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Contact: Yongping Song, Dr. +86-37165587795 songyongping2018@126.com
Contact: Quanli Gao, Dr. +86-37165587483 gaoquanli2015@126.com

Locations
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China, Henan
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Yongping Song, Dr.    +86-37165587795    songyongping2018@126.com   
Sub-Investigator: Quanli Gao, Dr.         
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Quanli Gao, M.D    +86-15038171966    gaoquanli2015@126.com   
Contact: Lu Han, M.D    +86-13838583031    luhan0377@163.com   
Sponsors and Collaborators
Henan Cancer Hospital
Henan Hualong Biotechnology Company
Investigators
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Study Chair: Yongping Song, Dr. Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03881761     History of Changes
Other Study ID Numbers: HenanCH CART 2-3
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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