A Phase 1/2 interventional study of anti-CD19 UCAR-NK cells in B-cell Lymphoma and B-cell Leukemia, sponsored by Kunming Hope of Health Hospital. Withdrawn at 1 site in China. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Kunming Hope of Health Hospital · Phase 1/2, Interventional, and Treatment
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 U-CAR-NK Cells Therapy combined with HSCT for B cell hematologic malignancies.
Who can participate? Patients who were diagnosed with B cell hematologic malignancies and tumor cells expressing CD19.
How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-CD19 U-CAR-NK cells, which belong to chimeric antigen receptor modified NK cells. The administration time is 1-7 days after hematopoietic stem cell infusion. Patients were then evaluated for long-term efficacy and safety until 2 years after U-CAR-NK cells infusion.
What are the possible benefits and risks of participating? Benefits: The Dual effect of anti-tumor and anti-infection of NK cells may be used to promote the engraftment of hematopoietic stem cell and better disease control.
Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly other unknown adverse reactions.
Where is the study run? Kunming Hope of Health Hospital.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
Browse Hematologic Neoplasms studies →Kunming Hope of Health Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will get infused with anti-CD19 CAR-NK cells within 1 week after hematopoietic stem cell infusion.
Biological: anti-CD19 UCAR-NK cells
Enrolled participants are chosen to receive one of three different dose levels of U-CAR-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.
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.
Time frame: Up to 12 months after infusion
Granulocyte implantation time
Time from hematopoietic stem cell transfusion to peripheral blood granulocyte count \>0.5×10\^9/L for 3 consecutive days.
Time frame: Up to 1 month after infusion
Platelet implantation time
Time from hematopoietic stem cell transfusion to peripheral blood platelet count \>20×10\^9/L for 7 consecutive days.
Time frame: Up to 1 month after infusion
Red blood cell implantation time
Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count \>70g/L.
Time frame: Up to 1 month after infusion
Duration of remission (DOR)
Duration of remission (DOR) refers to the time from the first assessment of CR or PR of the tumor to the first assessment of disease recurrence or progression or death from any cause.
Time frame: Up to 24 weeks after infusion
Disease control rate (DCR)
Disease control rate (DCR) are defined as the percentage of patients who have achieved complete response, partial response or stable disease to a therapeutic intervention in clinical trials of anticancer agents.
Time frame: Up to 24 weeks after infusion
Overall survival (OS)
Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-NK cells until death (from any cause).
Time frame: Up to 24 weeks after infusion
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the start of treatment with CAR-NK cells to the first progression of disease or death from any cause.
Time frame: Up to 24 weeks after infusion
This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Kunming Hope of Health Hospital