A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
Sponsor study identifier
interventional
75
1 country
1
Study Start
October 8, 2021
Actual (reported)Primary Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2021
Actual (reported)December 1, 2021
Actual (reported)March 3, 2022
Actual (reported)October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Titer of auto-antibody Titer of auto-antibody titer of auto-antibody
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003, China
He Huang, PhD
First Affiliated Hospital of Zhejiang University
First Submitted
December 1, 2021
First Posted
March 3, 2022
Study Start
October 8, 2021
Actual (reported)Primary Completion
October 1, 2024
Estimated (date passed)Overall response rate (ORR)
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Best overall response, BOR
At ≤3 month
Overall survival (OS)
From CD19/BCMA CAR-T infusion to death，up to 2 years
Duration of remission, DOR
2 years post CD19/BCMA CAR-T cells infusion
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 3, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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