B-cell Lymphoma Clinical Trial
Official title:
An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies
Verified date | November 2022 |
Source | Kunming Hope of Health Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients with indications for hematopoietic stem cell transplantation; 2. Age =75 years old; 3. Confirmed B-cell tumor and tumor cells expressing CD19; 4. Expected survival time >12 weeks; 5. ECOG score is 0-2; 6. Adequate liver , kidney and cardiopulmonary function; 7. Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Exclusion Criteria: 1. Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening; 2. At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening; 3. Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher GVHD requiring immunosuppressive therapy occurred within 2 weeks before screening; 4. Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression; 5. Have received live attenuated vaccine within 6 weeks before rinsing; 6. Had a cerebrovascular accident or seizure within 6 months before screening; 7. History of deep venous thrombosis or pulmonary embolism within 6 months before screening; 8. A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening; 9. Previous history of Alzheimer's disease; 10. Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening; 11. There are uncontrollable infections; 12. Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion; 13. Conditions that other researchers deemed inappropriate for participating in the study. |
Country | Name | City | State |
---|---|---|---|
China | Kunming Hope of Health Hospital | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Kunming Hope of Health Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Granulocyte implantation time | Time from hematopoietic stem cell transfusion to peripheral blood granulocyte count >0.5×10^9/L for 3 consecutive days. | Up to 1 month after infusion | |
Secondary | Platelet implantation time | Time from hematopoietic stem cell transfusion to peripheral blood platelet count >20×10^9/L for 7 consecutive days. | Up to 1 month after infusion | |
Secondary | Red blood cell implantation time | Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count >70g/L. | Up to 1 month after infusion | |
Secondary | 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. | Up to 24 weeks after infusion | |
Secondary | 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. | Up to 24 weeks after infusion | |
Secondary | 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). | Up to 24 weeks after infusion | |
Secondary | 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. | Up to 24 weeks after infusion |
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