Acute Myeloid LeukemiaPhase 1NCT05248685
Optimized Dual CD33/CLL1 CAR T Cells in Subjects With Refractory or Relapsed Acute Myeloid Leukemia
A Phase 1 study testing Dual CD33/CLL1 CAR T in people with Acute Myeloid Leukemia, run by Beijing Boren Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Dual CD33/CLL1 CAR T
- 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
- 16 Feb 2022to 31 Dec 2023
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Co-expression of tumor surface antigens CD33 and CLL1 was confirmed (among which, the proportion of cells expressing CD33 was ≥ 80%; and the proportion of cells expressing CLL1 ≥ 80%); patients with primary drug resistance, chemotherapy relapse, extramedullary relapse, persistent residual disease positive or relapsed/refractory acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation;
- Male or female, aged 1-70 years;
- No serious allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
- Have life expectancy of at least 60 days based on investigator's judgement;
- Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form; Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively.Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
- Diffuse intravascular coagulation;
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- Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value;
- Suffering from septicemia or other uncontrollable infections;
- Patients with uncontrollable diabetes;
- Severe mental disorders;
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);
- Have received organ transplantation (excluding bone marrow transplant);
- Reproductive-aged female patients with positive blood HCG test;
- Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis;
- For patients with CAR-T cells derived from autologous lymphocytes, leukemia blasts accounted for more than 30% of all cells in peripheral blood;
- Patients unable to provide a transplant donor about 30 days after the CAR-T cell transfusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-Label, Non-randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Optimized Dual CD33/CLL1 CAR T Cells in Subjects With Refractory or Relapsed Acute Myeloid Leukemia
This is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Dual CD33/CLL1 CAR T
- Keywords
- CAR-T, Leukemia, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual CD33/CLL1 CAR TBiological
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%)
| Study group | Role | What they receive |
|---|---|---|
| Dual CD33/CLL1 CAR T | Experimental | All patients who receive Dual CD33/CLL1 CAR T Cell infusion Receives: Biological: Dual CD33/CLL1 CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLT assessment according to the clinical study protocol
Measured: 21 days post intravenous injection
Incidence and severity of adverse events (AE)
Measured: 30 days post intravenous injection
Secondary outcomes (2)
Objective response rate (ORR)
Objective response rate (ORR) according to NCCN, Complete response (CR),CR with incomplete blood count recovery (CRi)
Measured: 28 days post infusion
Concentration of PK CAR positive T cells in peripheral blood
Proliferation and survival of CAR T cells in peripheral blood.
Measured: 30 days post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start16 Feb 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: no patients
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248685
- Sponsor's protocol ID
- BRYY-IIT-LCYJ-2021-026
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-Label, Non-randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Optimized Dual CD33/CLL1 CAR T Cells in Subjects With Refractory or Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05248685
- Acronym / sponsor ID
- BRYY-IIT-LCYJ-2021-026
- Conditions
- Acute Myeloid Leukemia
- Keywords
- CAR-T, Leukemia, Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Feb 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.
This is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual CD33/CLL1 CAR T | Experimental | Biological: Dual CD33/CLL1 CAR TAll patients who receive Dual CD33/CLL1 CAR T Cell infusion |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Co-expression of tumor surface antigens CD33 and CLL1 was confirmed (among which, the proportion of cells expressing CD33 was ≥ 80%; and the proportion of cells expressing CLL1 ≥ 80%); patients with primary drug resistance, chemotherapy relapse, extramedullary relapse, persistent residual disease positive or relapsed/refractory acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation;
- Male or female, aged 1-70 years;
- No serious allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
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 |
|---|---|---|
| Dual CD33/CLL1 CAR TSubjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) | Biological | Dual CD33/CLL1 CAR T |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 21 days post intravenous injection
DLT assessment according to the clinical study protocol
Incidence and severity of adverse events (AE)
Time frame: 30 days post intravenous injection
2 secondary outcomes
Objective response rate (ORR)
Time frame: 28 days post infusion
Concentration of PK CAR positive T cells in peripheral blood
Time frame: 30 days post 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 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dual CD33/CLL1 CAR T in people with Acute Myeloid Leukemia, run by Beijing Boren 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 16 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 11 Jun 2025. 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 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.
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?
Dose limiting toxicity (DLT) (time frame: 21 days post intravenous injection). The study lists 2 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 11 Jun 2025.