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CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

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ClinicalTrials.gov Identifier: NCT03121625
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Hebei Medical University Fourth Hospital
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 hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Autologous CAR-T 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. Besides CD19, many other molecules such as CD22, CD30, CD7, BCMA, CD123, 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 : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Actual Study Start Date : December 26, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021

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
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
Criteria

Inclusion Criteria:

1.The treat history meeting the following criteria:

  1. Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
  2. Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
  3. One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.

2. There is a measurable lesions before treatment at least; 3. ECOG score≤2; 4. To be aged 1 to 70 years; 5. 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 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 ClinicalTrials.gov identifier (NCT number): NCT03121625


Contacts
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Contact: Jianqiang Li, PhD & MD 008615511369555 limmune@gmail.com

Locations
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China, Hebei
Hematology Department, Hebei Medical University Fourth Hospital Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Lihong Liu, PhD & MD    +8613831177920    limmune@gmail.com   
Contact: PhD & MD         
Principal Investigator: Lihong Liu, PhD & MD         
Sub-Investigator: Jianqiang Li, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Lihong Liu, PhD & MD Hebei Medical University Fourth Hospital
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT03121625    
Other Study ID Numbers: 2016040
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
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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Neoplasms