- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654038
A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 UCAR-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 UCAR-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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Sanbin Wang, MD
- Phone Number: +86 13187424131
- Email: Sanbin1011@163.com
Study Locations
-
-
Yunnan
-
Kunming, Yunnan, China, 650000
- Recruiting
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
-
Contact:
- Chen Li
- Phone Number: 0871 64774206
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with indications for hematopoietic stem cell transplantation;
- Age ≤75 years old;
- Confirmed B-cell tumor and tumor cells expressing CD19;
- Expected survival time >12 weeks;
- Eastern cooperative oncology group (ECOG) score is 0-2;
- Adequate liver , kidney and cardiopulmonary function;
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
Exclusion Criteria:
- Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;
- At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;
- 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 graft versus host disease(GVHD) requiring immunosuppressive therapy occurred within 2 weeks before screening;
- Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
- Have received live attenuated vaccine within 6 weeks before rinsing;
- Had a cerebrovascular accident or seizure within 6 months before screening;
- History of deep venous thrombosis or pulmonary embolism within 6 months before screening;
- A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;
- Previous history of Alzheimer's disease;
- 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;
- There are uncontrollable infections;
- 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;
- Conditions that other researchers deemed inappropriate for participating in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target CD19 UCAR-NK cells
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events(AE) after infusion
Time Frame: Up to 12 months 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Granulocyte implantation time
Time Frame: Up to 1 month after infusion
|
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
|
Platelet implantation time
Time Frame: Up to 1 month after infusion
|
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
|
Red blood cell implantation time
Time Frame: Up to 1 month after infusion
|
Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count >70g/L.
|
Up to 1 month after infusion
|
Disease control rate (DCR)
Time Frame: Up to 24 weeks after infusion
|
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
|
Overall survival (OS)
Time Frame: Up to 24 weeks after infusion
|
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
|
Progression-free survival (PFS)
Time Frame: Up to 24 weeks after infusion
|
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
|
Duration of remission (DOR)
Time Frame: Up to 24 weeks after infusion
|
Duration of remission (DOR) refers to the time from the first assessment of complete response(CR) or partial response(PR) of the tumor to the first assessment of disease recurrence or progression or death from any cause.
|
Up to 24 weeks after infusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KM-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on B-Cell Lymphoblastic Leukemia/Lymphoma
-
Beijing Tongren HospitalRecruitingB-cell Lymphoma | Diffuse Large B Cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Yan'an Affiliated Hospital of Kunming Medical UniversityRecruitingB Cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Yan'an Affiliated Hospital of Kunming Medical UniversityKAEDIUnknownB Cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Novartis PharmaceuticalsRecruitingDiffuse Large B-cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaJapan, Canada
-
Pinze Lifetechnology Co. Ltd.Chinese Academy of Sciences; Navy General Hospital, BeijingUnknownB-cell Lymphoma | B-cell Acute Lymphoblastic LeukemiaChina
-
Nanfang Hospital of Southern Medical UniversityRecruitingB Cell Lymphoma | B-cell Acute Lymphoblastic Leukemia | B Cell Leukemia | B-cell Lymphoma Refractory | B-cell Lymphoma RecurrentChina
-
Shenzhen BinDeBio Ltd.Xiangya Hospital of Central South UniversityRecruitingRelapsed B-cell Acute Lymphoblastic Leukemia, Childhood | Refractory B-cell Acute Lymphoblastic Leukemia, Childhood | Relapsed/Refractory B-cell Lymphoma, ChildhoodChina
-
University Hospital HeidelbergRecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Chronic Lymphocytic Leukemia | Diffuse Large B Cell Lymphoma | Acute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, AdultGermany
-
Shenzhen BinDeBio Ltd.The First Affiliated Hospital of Zhengzhou UniversityUnknownRefractory B-cell Acute Lymphoblastic Leukemia | Relapsed B-cell Acute Lymphoblastic Leukemia | Relapsed/Refractory B-cell LymphomaChina
-
Shenzhen BinDeBio Ltd.Children's Hospital of Fudan UniversityActive, not recruitingRelapsed B-cell Acute Lymphoblastic Leukemia, Childhood | Refractory B-cell Acute Lymphoblastic Leukemia, Childhood | Relapsed/Refractory B-cell Lymphoma, ChildhoodChina
Clinical Trials on Anti-CD19 UCAR-NK cells
-
Kunming Hope of Health HospitalWithdrawnB-cell Lymphoma | B-cell LeukemiaChina
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.The First People's Hospital of Hefei; Hefei Binhu HospitalUnknownFollicular Lymphoma | Mantle Cell Lymphoma | Chronic Lymphocytic Leukemia | Acute Lymphocytic Leukemia | Diffuse Large Cell Lymphoma | B-cell Prolymphocytic LeukemiaChina
-
Allife Medical Science and Technology Co., Ltd.UnknownRefractory B-Cell Lymphoma
-
Allife Medical Science and Technology Co., Ltd.Peking University Cancer Hospital & InstituteUnknownRefractory B-Cell Lymphoma
-
Allife Medical Science and Technology Co., Ltd.Peking University Cancer Hospital & InstituteUnknownRefractory B-Cell Lymphoma
-
Xuzhou Medical UniversityRecruitingB-cell Lymphoma | Acute Lymphoblastic Leukemia | Chronic Lymphocytic LeukemiaChina
-
YANRU WANGRui Therapeutics Co., LtdRecruiting
-
Changhai HospitalNanjing Enricnk Biotech Co., LtdRecruitingDiffuse Large B Cell LymphomaChina
-
Changzhou No.2 People's HospitalRui Therapeutics Co., LtdNot yet recruitingThrombocytopenia Alloimmune
-
Changhai HospitalRui Therapeutics Co., LtdRecruitingSystemic Lupus Erythematosus (SLE)China