B-cell LymphomaPhase 1/2NCT05570188
Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies
A Phase 1/2 study testing anti-CD19 UCAR-NK cells in people with B-cell Lymphoma and B-cell Leukemia, run by Kunming Hope of Health Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- B-cell Lymphoma, B-cell Leukemia
- What is being tested?
- anti-CD19 UCAR-NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- B-cell Lymphoma, B-cell Leukemia
- Being tested
- anti-CD19 UCAR-NK cells
- Keywords
- universal CAR-NK, Hematopoietic Stem Cell Transplantation(HSCT)
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 UCAR-NK cellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will get infused with anti-CD19 CAR-NK cells within 1 week after hematopoietic stem cell infusion. Receives: Biological: anti-CD19 UCAR-NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after infusion
Secondary outcomes (7)
Granulocyte implantation time
Time from hematopoietic stem cell transfusion to peripheral blood granulocyte count >0.5×10^9/L for 3 consecutive days.
Measured: 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.
Measured: Up to 1 month after infusion
Red blood cell implantation time
Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count >70g/L.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 24 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Why it stopped: The PI decides to stop.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Hope of Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Principal investigator, Kunming Hope of Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570188
- Sponsor's protocol ID
- PBC042
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05570188
- Acronym / sponsor ID
- PBC042
- Conditions
- B-cell Lymphoma, B-cell Leukemia
- Keywords
- universal CAR-NK, Hematopoietic Stem Cell Transplantation(HSCT)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI decides to stop.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kunming Hope of Health HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: anti-CD19 UCAR-NK cellsPatients will get infused with anti-CD19 CAR-NK cells within 1 week after hematopoietic stem cell infusion. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- ECOG score is 0-2;
Key exclusion criteria (13 listed)
- 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 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-CD19 UCAR-NK cellsEnrolled 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. | Biological | Treatment group |
Primary outcome
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.
7 secondary outcomes
Granulocyte implantation time
Time frame: Up to 1 month after infusion
Platelet implantation time
Time frame: Up to 1 month after infusion
Red blood cell implantation time
Time frame: Up to 1 month after infusion
Duration of remission (DOR)
Time frame: Up to 24 weeks after infusion
Disease control rate (DCR)
Time frame: Up to 24 weeks after infusion
Overall survival (OS)
Time frame: Up to 24 weeks after infusion
Progression-free survival (PFS)
Time frame: Up to 24 weeks after infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, MD principal investigator
Kunming Hope of Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anti-CD19 UCAR-NK cells in people with B-cell Lymphoma and B-cell Leukemia, run by Kunming Hope of Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: Up to 12 months after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.