Back to resultsCAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Primary Purpose
Leukemia, Lymphoma, Multiple Myeloma of Bone (Diagnosis)
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia
Eligibility Criteria
Inclusion Criteria:
- Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
- ECOG score≤2;
- To be aged 1 to 70 years;
- More than a month lifetime from the consent signing date.
Exclusion Criteria:
- Serious cardiac insufficiency, left ventricular ejection fraction<50%;
- Has a history of severe pulmonary function damaging;
- Merging other progressing malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C;
- Patients with HIV infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
- Pregnancy or lactation women;
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Sites / Locations
- Hebei Yanda Ludaopei HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous CAR-T cells
Arm Description
Patients will be be treated with autologous CAR-T cells
Outcomes
Primary Outcome Measures
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Secondary Outcome Measures
CAR-T cell persistence
CAR-T cell persistence will be quantified with flow cytometry and qPCR
Full Information
NCT ID
NCT03312205
First Posted
October 12, 2017
Last Updated
January 8, 2019
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital, Beijing Lu Daopei Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03312205
Brief Title
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Official Title
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
August 29, 2019 (Anticipated)
Study Completion Date
August 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital, Beijing Lu Daopei Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Multiple Myeloma of Bone (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous CAR-T cells
Arm Type
Experimental
Arm Description
Patients will be be treated with autologous CAR-T cells
Intervention Type
Biological
Intervention Name(s)
Autologous CAR-T cells
Intervention Description
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 Measure Information:
Title
Tumor load
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
CAR-T cell persistence
Description
CAR-T cell persistence will be quantified with flow cytometry and qPCR
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
ECOG score≤2;
To be aged 1 to 70 years;
More than a month lifetime from the consent signing date.
Exclusion Criteria:
Serious cardiac insufficiency, left ventricular ejection fraction<50%;
Has a history of severe pulmonary function damaging;
Merging other progressing malignant tumor;
Merging uncontrolled infection;
Merging the metabolic diseases (except diabetes);
Merging severe autoimmune diseases or immunodeficiency disease;
Patients with active hepatitis B or hepatitis C;
Patients with HIV infection;
Has a history of serious allergies on Biological products (including antibiotics);
Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
Pregnancy or lactation women;
Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peihua Lu, PhD & MD
Phone
18611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang Li, PhD & MD
Phone
008615511369555
Email
limmune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Lu, PhD & MD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD & MD
Phone
008618611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD & MD
First Name & Middle Initial & Last Name & Degree
Jianqiang Li, PhD & MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
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