CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04508842|
Recruitment Status : Suspended (Adjustment plan)
First Posted : August 11, 2020
Last Update Posted : February 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Refractory and Relapsed B Cell Acute Leukemia||Biological: CD19/CD22-Dual-STAR-T||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Phase I Efficacy and Safety Clinical Study of CD19/CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL.|
|Estimated Study Start Date :||May 1, 2022|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||December 10, 2022|
CD19/CD22-Dual-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of Dual-STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 500mg/m2 for 3 days and take a rest for 2 days before infusion. Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
- Percentage of participants with adverse events. [ Time Frame: 12 months ]Percentage of participants with adverse events.
- Objective Remission Rate(ORR) [ Time Frame: 12 months ]The percentage of participants who achieved complete remission(CR) and CR in over all participants.
- Proliferation ratio of Dual-STAR-T cells [ Time Frame: 12 months ]
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): NCT04508842
|Hebei Yanda Ludaopei Hospital|
|Sanhe, Hebei, China, 065200|
|Study Director:||Xian Zhang, PhD||Hebei Yanda Ludaopei Hospital|