Acute Myeloid LeukemiaNCT05943314
Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia
A study testing CLL1/+CD33 CAR-T in people with Acute Myeloid Leukemia, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial summary
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CLL1/+CD33 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 28 Aug 2023
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
- Age range 1-18 years;
- Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;
- The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;
- The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
- ECOG score was 0-2.
Who cannot join
- The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
- Active hepatitis B/C virus;
- HIV infection, treponema syphilis positive patients;
- Pathological diagnosis of primary tumors other than acute myeloid leukemia;
- Suffering from serious autoimmune diseases or immunodeficiency diseases;
- The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;
- Pregnant or lactating women;
- Patients who were considered ineligible for study for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
Read the detailed description
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CLL1/+CD33 CAR-T
- Keywords
- AML, CLL1, CD33
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLL1/+CD33 CAR-TBiological
CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia.
| Study group | Role | What they receive |
|---|---|---|
| CLL1/+CD33 CAR-T | Experimental | The target dose range for subjects was set to be 1.00~2.50x10^6/kg CAR-positive T cells. Receives: Biological: CLL1/+CD33 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
Measured: CAR T cell infusion before and 12 months after infusion
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by flow cytometry
Measured: CAR T cell infusion before and 12 months after infusion
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction（qPCR）
Measured: CAR T cell infusion before and 12 months after infusion
Secondary outcomes (4)
Event-free survival
Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.
Measured: Up to 12 months after CLL1/+CD33 CAR-T infusion
Overall survival
Death from any cause from the beginning of cell transfusion
Measured: Up to 12 months after CLL1/+CD33 CAR-T infusion
Duration of Overall Response
The time from the start of cell infusion when CR or PR is first achieved to disease progression.
Measured: Up to 12 months after CLL1/+CD33 CAR-T infusion
MRD negative rate
The rate of MRD negative subjects was determined by flow cytometry.
Measured: Up to 12 months after CLL1/+CD33 CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start12 Jul 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Why it stopped: The clinical trial was terminated due to a change in sponsor strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Zhang, doctor, Principal investigator, Children's Hospital of Fujian Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943314
- Sponsor's protocol ID
- BG-CT-21-001
- Status last verified
- Oct 2023
- First submitted
- 9 Jun 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study
- ClinicalTrials.gov ID
- NCT05943314
- Acronym / sponsor ID
- BG-CT-21-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, CLL1, CD33
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The clinical trial was terminated due to a change in sponsor strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 13 Jul 2023 (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.
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
Detailed description
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLL1/+CD33 CAR-T | Experimental | Biological: CLL1/+CD33 CAR-TThe target dose range for subjects was set to be 1.00~2.50x10^6/kg CAR-positive T cells. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
- Age range 1-18 years;
- Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;
- The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;
- The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
Key exclusion criteria (8 listed)
- The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
- Active hepatitis B/C virus;
- HIV infection, treponema syphilis positive patients;
- Pathological diagnosis of primary tumors other than acute myeloid leukemia;
- Suffering from serious autoimmune diseases or immunodeficiency diseases;
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 |
|---|---|---|
| CLL1/+CD33 CAR-TCLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia. | Biological | CLL1/+CD33 CAR-T |
Primary outcome
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
Time frame: CAR T cell infusion before and 12 months after infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
Time frame: CAR T cell infusion before and 12 months after infusion
Track CAR-T cells expansion in patients after infusion by flow cytometry
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
Time frame: CAR T cell infusion before and 12 months after infusion
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction（qPCR）
4 secondary outcomes
Event-free survival
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
Overall survival
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
Duration of Overall Response
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
MRD negative rate
Time frame: Up to 12 months after CLL1/+CD33 CAR-T 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 2 Nov 2023.
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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.
Hui Zhang, doctor principal investigator
Children's Hospital of Fujian Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLL1/+CD33 CAR-T in people with Acute Myeloid Leukemia, run by Guangzhou Bio-gene Technology Co., Ltd 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 6 inclusion and 8 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 2 Nov 2023. 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.
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?
Changes in cytokine level after CLL1/+CD33 CAR-T infusion (time frame: CAR T cell infusion before and 12 months after infusion). The study lists 3 primary outcomes in all. 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 2 Nov 2023.