Status:
UNKNOWN
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsors:
Hebei Yanda Ludaopei Hospital
Beijing Lu Daopei Hospital
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
1-70 years
Phase:
PHASE1
PHASE2
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 ma...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03312205
Start Date
August 29 2017
End Date
August 29 2023
Last Update
January 9 2019
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China, 065000