A Phase 2 interventional study of CAR-T in B Cell Lymphoma, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
Exclusion Criteria:
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
Combination Product: CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
complete remission rate
complete remission rate after treated by CAR-T therapy
Time frame: every 3 months until 20 months after the last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 20 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of the start of treatment to 20 months after last patient's enrollment
duration of the modified T cells by CAR-T in the patients
time from re-transfusion to date when the modified T cells become non-detectable.
Time frame: from the date of re-transfusison to 20 months after last patient's enrollment
Plan to share: Yes — All the data would be available on the corresponding website of the leading research center.
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University