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CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

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: NCT04626739
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

Condition or disease Intervention/treatment Phase
Refractory Indolent Adult Non-Hodgkin Lymphoma Drug: CD19 CAR-T Drug: CD22 CAR-T Drug: CD19+CD22 CAR-T Drug: Fludarabine Drug: Cyclophosphamide Early Phase 1

Detailed Description:
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: volunteers
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma
Drug: CD19 CAR-T
CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
Other Name: Senl_19

Drug: CD22 CAR-T
CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
Other Name: Senl_22

Drug: CD19+CD22 CAR-T
CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
Other Name: Senl_19+22

Drug: Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Other Name: flu

Drug: Cyclophosphamide
500mg/㎡ for D-3 and D-2
Other Name: ctx

Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events as a Measure of Safety [ Time Frame: 28 days ]
    Number of Participants with Severe/Adverse Events as a Measure of Safety

  2. CAR-T Cell expansion level [ Time Frame: 24 months ]
    Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

Secondary Outcome Measures :
  1. Objective response rate of complete remission and partial remission [ Time Frame: 24 months ]
    Objective response rate of complete remission and partial remission

  2. Overall survival time [ Time Frame: 24 months ]
    Overall survival time

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
  2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.

    To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;

  3. There should be at least one measurable tumor focal point;
  4. Karnofsky [2] score 50 or more;
  5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
  6. The expected survival time is greater than 3 months;
  7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction<50;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other malignant tumor;
  4. Merging uncontrolled infection;
  5. Merging the metabolic diseases (except diabetes);
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. patients with active hepatitis B or hepatitis C;
  8. patients with HIV infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
  11. Pregnancy or lactation women;
  12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

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): NCT04626739

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Contact: Jianqiang Li, Phd&MD 86-311-82970975

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China, Hebei
No.2 Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Jianqiang Li, PhD & MD    +86311-89928689   
Contact: Jianmin Luo, PhD & MD    +86311-66002304      
Principal Investigator: Jianmin Luo, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
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Principal Investigator: Jianmin luo, PhD&MD The Second Hospital of Hebei Medical University
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd. Identifier: NCT04626739    
Other Study ID Numbers: CAR-T for NHL
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
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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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists