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CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid 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: NCT03312205
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : January 9, 2019
Hebei Yanda Ludaopei Hospital
Beijing Ludaopei Hospital
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Multiple Myeloma of Bone (Diagnosis) Biological: Autologous CAR-T cells Phase 1 Phase 2

Detailed Description:
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA, CLL-1, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. 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 : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : August 29, 2019
Estimated Study Completion Date : August 29, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Autologous CAR-T cells
Patients will be be treated with autologous CAR-T cells
Biological: Autologous CAR-T cells
Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Primary Outcome Measures :
  1. Tumor load [ Time Frame: Up to 24 months ]
    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures :
  1. CAR-T cell persistence [ Time Frame: Up to 24 months ]
    CAR-T cell persistence will be quantified with flow cytometry and qPCR

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
  2. ECOG score≤2;
  3. To be aged 1 to 70 years;
  4. More than a month lifetime from the consent signing date.

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other progressing 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. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
  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): NCT03312205

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Contact: Peihua Lu, PhD & MD 18611636172
Contact: Jianqiang Li, PhD & MD 008615511369555

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China, Hebei
Hebei Yanda Ludaopei Hospital Recruiting
Langfang, Hebei, China, 065000
Contact: Peihua Lu, PhD & MD    008618611636172   
Principal Investigator: Peihua Lu, PhD & MD         
Sub-Investigator: Jianqiang Li, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Yanda Ludaopei Hospital
Beijing Ludaopei Hospital
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Study Chair: Peggy Lu, PhD & MD Hebei Yanda Ludaopei Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd. Identifier: NCT03312205    
Other Study ID Numbers: daopeicart
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases