An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(UCAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies
Sponsor study identifier
interventional
30
1 country
1
Study Start
December 8, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 universal CAR-NK(UCAR-NK) cells therapy combined with HSCT for B cell hematologic malignancies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 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.
December 7, 2022
Actual (reported)December 8, 2022
Actual (reported)December 16, 2022
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.
Up to 12 months after infusion
Granulocyte implantation time
Up to 1 month after infusion
Platelet implantation time
Up to 1 month after infusion
Red blood cell implantation time
Up to 1 month after infusion
Duration of remission (DOR)
Up to 24 weeks after infusion
Disease control rate (DCR)
Up to 24 weeks after infusion
Subjects who meet the enrollment conditions will receive intravenous infusion of anti-CD19 UCAR-NK Cells within 1 week after hematopoietic stem cell infusion.
The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of UCAR-NK cells:Dose level one: 5-10×10\^6/kg; Dose level two:1-2×10\^7/kg; Dose level three:2-5×10\^7/kg.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650000, China
Sanbin Wang, MD
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
First Submitted
December 7, 2022
First Posted
December 16, 2022
Study Start
December 8, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 21, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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