AMLPhase 1NCT05467202
Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AML
A Phase 1 study testing CLL1 CAR-T in people with AML, run by Zhejiang University at 1 site in China.
Trial summary
This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- AML
- What is being tested?
- CLL1 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 2 Aug 2025
- 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
- Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- The expression of CLL1 in AML blast is positive ;
- The patient has recovered from the toxicity of previous treatment;
- ECOG score ≤ 2 and expected survival period is not less than 3 months;
- Adequate organ function defined as:
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- AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
- Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
- From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception
Who cannot join
- Diagnosis of acute promyelocytic leukemia;
- History or presence of a CNS disorder;
- HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
- History of severe hypersensitivity reaction;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
- History of organ transplant surgery;
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- Required systemic application of immunosuppressive or other drugs;
- Auto-SCT within the 3 months before enrollment;
- Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
- Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
- Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
- Live vaccine received within the ≤ 4 weeks before enrollment;
- Persons with serious mental illness;
- History of major surgical operations four weeks before enrollment;
- History of alcoholism or substance abuse;
- Was identified by the investigators as unsuitable to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou
Mingming Zhang, MD, 13656674208, mingmingzhang@zju.edu.cn
About this study
Official title: To Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With Relapsed and Refractory Acute Myeloid Leukemia
This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia
- Conditions
- AML
- Being tested
- CLL1 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLL1 CAR-TDrug
A single infusion of autologous CLL1 CAR-T cells administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Dose Escalation:After enrollment ,Participants complete the PBMC apheresis,then complete the Lymphocyte clearance,and then receive the dose climning test: 3×10e6/kg，6 ×10e6/kg，9×10e6/kg.
Dose Expansion:Participants receive a single dose (at the MTD determined). Receives: Drug: CLL1 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Count the Incidence of adverse events
Measured: Up to 2 years after CLL1 CAR-T infusion
Changes in cytokine level after CLL1 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CLL1 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.
Measured: Up to 2 years after CLL1 CAR-T infusion
Secondary outcomes (3)
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Measured: Up to 2 years after CLL1 CAR-T infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Measured: Up to 2 years after CLL1 CAR-T infusion
Overall response Rate(ORR)
Proportion of subjects who achieved CR, CRi, or PR
Measured: Up to 2 years after CLL1 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 posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion2 Aug 2024 (estimated)
- Study completion2 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467202
- Sponsor's protocol ID
- BG-CT-22-002(CLL1)
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With Relapsed and Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05467202
- Acronym / sponsor ID
- BG-CT-22-002(CLL1)
- Conditions
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 2 Aug 2024 (estimated)
- Study completion
- 2 Aug 2025 (estimated)
- First posted
- 20 Jul 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 an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia
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 | Drug: CLL1 CAR-TDose Escalation:After enrollment ,Participants complete the PBMC apheresis,then complete the Lymphocyte clearance,and then receive the dose climning test: 3×10e6/kg，6 ×10e6/kg，9×10e6/kg. Dose Expansion:Participants receive a single dose (at the MTD determined). |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
- Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- The expression of CLL1 in AML blast is positive ;
- The patient has recovered from the toxicity of previous treatment;
- ECOG score ≤ 2 and expected survival period is not less than 3 months;
Key exclusion criteria (16 listed)
- Diagnosis of acute promyelocytic leukemia;
- History or presence of a CNS disorder;
- HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
- History of severe hypersensitivity reaction;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
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 CAR-TA single infusion of autologous CLL1 CAR-T cells administered intravenously | Drug | Treatment group |
Primary outcome
Evaluation of Safety
Time frame: Up to 2 years after CLL1 CAR-T infusion
Count the Incidence of adverse events
Changes in cytokine level after CLL1 CAR-T infusion
Time frame: Up to 2 years after CLL1 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CLL1 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.
3 secondary outcomes
Complete response rate(CRR)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Partial response Rate (PRR)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Overall response Rate(ORR)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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.
He Huang, MD principal investigator
First Affiliated Hospital of Zhejiang University
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 CLL1 CAR-T in people with AML, run by Zhejiang University 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 9 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: status not confirmed, as of the sponsor's last update on 20 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingming Zhang, MD (13656674208, mingmingzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Up to 2 years after CLL1 CAR-T infusion). 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 20 Jul 2022.