CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell Malignancies
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|ClinicalTrials.gov Identifier: NCT03559439|
Recruitment Status : Unknown
Verified November 2020 by Liu Ligen, Shanghai Tong Ren Hospital.
Recruitment status was: Recruiting
First Posted : June 18, 2018
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-cell Malignancy B-cell Lymphoma B-Cell Acute Lymphoblastic Leukaemia||Biological: CD19 CAR T||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD19-targeting CAR T Cell Therapy in the Treatment of Relapsed or Refractory CD19 Positive B-cell Malignancies|
|Actual Study Start Date :||April 24, 2018|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: CD19 CAR T
CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion.
Biological: CD19 CAR T
CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.
- Frequency and severity of toxicities and adverse events [ Time Frame: 24 weeks ]To assess the frequency and severity of toxicities and adverse events according to NCI CTC v4.0
- overall response rate [ Time Frame: 24 week ]To assess the overall response rate after CD19 CAR T infusion in R/R B cell malignancies
- overall survival [ Time Frame: 24 week ]To assess the overall survival in patients with R/R B cell malignancies
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): NCT03559439
|Contact: Ligen Liuemail@example.com|
|Shanghai Tong Ren hospital||Recruiting|
|Contact: Ligen Liu 18017337037 firstname.lastname@example.org|
|Principal Investigator:||Ligen Liu||Shanghai Tong Ren Hospital|