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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

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

Condition or disease Intervention/treatment Phase
Refractory Relapsed B Cell Lymphoma B Cell Leukemia Biological: CAR-T cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: CAR-T cell group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 27, 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: Leukemia

Arm Intervention/treatment
Experimental: experimental arm
cord blood derived CAR T cells group
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

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 ]
    the proportion of patients with CR or PR

  2. progression-free survival [ Time Frame: one year ]
    from the date of enrollment to the first date of progression detected

  3. overall survival [ Time Frame: one year ]
    from the date of enrollment to the date of death

  4. copy number of CAR-T [ Time Frame: six months ]
    copy number of CAR-T in blood and bone marrow

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03881774

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Contact: Yongping Song, Dr. +86-37165587795
Contact: Quanli Gao, Dr. +86-37165587483

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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Quanli Gao, M.D    +86-15038171966   
Contact: Lu Han, M.D    +86-13838583031   
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Yongping Song, M.D    +86-37165587795   
Sponsors and Collaborators
Henan Cancer Hospital
Henan Hualong Biotechnology Company
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Study Chair: Yongping Song, Dr. Henan Cancer Hospital
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Responsible Party: Henan Cancer Hospital Identifier: NCT03881774    
Other Study ID Numbers: HenanCH CART 2-4
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid