CD19-CAR-T Cells in Patients With R/R B-ALL
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|ClinicalTrials.gov Identifier: NCT03574168|
Recruitment Status : Unknown
Verified June 2018 by Bioceltech Therapeutics, Ltd..
Recruitment status was: Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia||Biological: CD19-CAR-T Cells||Phase 1|
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
To Assess the patient's quality of life after receiving the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)|
|Estimated Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: CD19-CAR-T Cells
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Biological: CD19-CAR-T Cells
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
- Objective Response Rate, ORR [ Time Frame: Up to Day90 after the CD19-CAR-T cell infusion ]
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
The percentage of participants who achieved partial remission (PR) over all participants (PRR).
- The amount of CAR-T cells remaining in vivo [ Time Frame: 2 years after cell infusion. ]Measure and analyze monthly
- The lifetime of CAR-T cells remaining in vivo [ Time Frame: 2 years after cell infusion. ]Measure and analyze monthly
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): NCT03574168
|Contact: Zhongwei Xu, MD, Phd||+86 email@example.com|
|Hebei Yanda Ludaopei Hospital||Recruiting|
|Langfang, Hebei, China, 065000|
|Contact: Peihua Lu, MD, PhD 18611636172 firstname.lastname@example.org|
|Principal Investigator:||Peihua Lu, MD, PhD||Hebei Yanda Ludaopei Hospital|