AML M4Early Phase 1NCT04803929
Clinical Study of Anti-ILT3 CAR-T Therapy for R/R AML(M4/M5)
A Early Phase 1 study testing anti-ILT3 CAR-T in people with AML M4 and AML M5, run by Carbiogene Therapeutics Co. Ltd. at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (M4/M5). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- anti-ILT3 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2021to 1 Mar 2026
- Phase
- Early 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged ≥18 years or ≤70 years;
- Acute myeloid leukemia AML M4/M5 subtype was diagnosed according to Fab standard classification, confirmed by bone marrow IHC or ILT3-positive expression by flow cytometry in monocytes (primary and young monocytes in bone marrow ≥20%)
- Relapsed/refractory patients, whose conditions meet:
- Recurrent AML diagnosis standard: complete remission (CR) after the original cells in peripheral blood again leukemia cells or bone marrow > 0.050 (with the exception of consolidation chemotherapy after bone marrow regeneration for other reasons) or myeloid leukemia cells infiltrating outside.
- Refractory AML diagnostic criteria: after two standard regimen for treatment invalid early cure; patients who relapsed within 12 months after consolidation and intensive treatment after CR; relapsed after 12 months but failed to respond to conventional chemotherapy; 2 or more recurrences; patients with persistent extramedullary leukemia.
- Main organ functions meet the following conditions:
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- Kidney function: creatinine clearance (absolute value) or 60 ml/min or creatinine < 2.0 mg/dl or < 2 times the subjects' age group upper limit of normal (ULN) blood.
- Liver function: ALT ≤ 3 or less ULN, AST ≤ 3 or less ULN.
- Heart function: the ejection fraction ≥ 50%, measured by echocardiography (ECHO) or more acquisition scan (MUGA).
- Lung function: no clinical significance of pleural effusion, baseline blood oxygen saturation > 92%.
- ECOG physical status score 0-3.
- No use of steroid hormones within 2 weeks.
- Sufficient venous access to single or venous blood collection is available, and there are no other contraindications to blood cell separation.
- Signed written informed consent form.
Who cannot join
- Subjects will not be included in the study if they meet any of the following criteria:
- Pregnant or lactating women;
- HIV serological positive;
- Active bacterial, fungal or viral infections that are not controlled by treatment;
- Suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage or other serious cardiovascular and cerebrovascular diseases;
- History and concomitant diseases:
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- Subjects with known or suspected autoimmune diseases or immunodeficiency diseases;
- Subjects requiring systemic treatment with corticosteroids or other immunosuppressive agents during treatment;
- Subjects who have previously received other gene therapies;
- Subjects with a history of organ transplantation (referring to solid organ transplantation);
- Subjects with severe mental disorders;
- Participated in other clinical studies within one month before the collection of PBMC;
- Uncontrolled active hepatitis B and/or C infection (hepatitis B: HBV DNA > 500 IU/ml or copy number > 2500 copies /ml;
- Hepatitis C: HCV antibody positive and HCV-RNA levels above the detection limit);
- Any serious or uncontrolled disease that the Investigator considers to be likely to increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive the study drug;
- Subjects who underwent major surgery or suffered significant trauma within 4 weeks prior to the collection of PBMCs, or who are expected to require major surgery during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincal People's Hospital
Hangzhou, Zhejiang
Lai Jin, +86-18458227035, hjdl188@sina.com
Jianping Lan
About this study
Official title: Clinical Study of Autologous T Cells Modified With ILT3 Chimeric Antigen Receptor for Relapsed/Refractory Acute Myeloid Leukemia (M4/M5)
This study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (M4/M5).
Read the detailed description
Our group has developed a novel anti-ILT3 CAR T cell therapy, and this pilot study is focused on the safety and efficacy of the anti-ILT3 CAR-T for R/R AML(M4/M5) patients. A total of 25 subjects are intravenously adminstered with anti-ILT3 CAR-T cells. The dosages of CAR-T cells follow the "3+3" dose increment program.
- Being tested
- anti-ILT3 CAR-T
- Medical subject headings
- Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-ILT3 CAR-TBiological
Autologous T cells genetically modified with anti-ILT3 CAR
| Study group | Role | What they receive |
|---|---|---|
| Anti-ILT3 CAR-T cells | Experimental | All subjects were intravenous administrated with anti-ILT3 CAR-T cells Receives: Biological: anti-ILT3 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grade 3 or 4 treatment related adverse effects
All the CAR-T treatment related adverse events，including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.
Measured: up to 24 weeks after first infusion
Implantation endpoint
To assess the duration of CAR-positive T cells in circulation, the copy number of CAR DNA was measured at the preset follow-up time point. The time when the results of any two consecutive tests were negative, were recorded as the "implantation endpoint"
Measured: up to 2 years after first infusion
Secondary outcomes (5)
Disease specific response
Disease specific response includes, but are not limited to, complete response (CR) including morphological leukemia-free status, morphological CR, cytogenetic CR, molecular CR, and partial response (PR).
Measured: up to 2 years after first infusion
Overall survival
From date of inclusion to date of progression, relapse, or death from any cause
Measured: up to 2 years after inclusion
Progress-free survival
The length of time that a participant's disease did not progress during and after CAR-T treatment
Measured: up to 2 years after inclusion
CAR-T residue
The residue of CAR-positive T cells in circulation determined by flow cytometry
Measured: up to 2 years after first infusion
Minimal residual disease (MRD)
MRD is a status that none tumor cells can be detected by standard cell morphology.
Measured: up to 2 years after first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start3 Mar 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML M4Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carbiogene Therapeutics Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jianping Lan, Principal investigator, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803929
- Sponsor's protocol ID
- 2021KY014
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Autologous T Cells Modified With ILT3 Chimeric Antigen Receptor for Relapsed/Refractory Acute Myeloid Leukemia (M4/M5)
- ClinicalTrials.gov ID
- NCT04803929
- Acronym / sponsor ID
- 2021KY014
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Carbiogene Therapeutics Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial People's Hospital
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Mar 2021 (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 study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (M4/M5).
Detailed description
Our group has developed a novel anti-ILT3 CAR T cell therapy, and this pilot study is focused on the safety and efficacy of the anti-ILT3 CAR-T for R/R AML(M4/M5) patients. A total of 25 subjects are intravenously adminstered with anti-ILT3 CAR-T cells. The dosages of CAR-T cells follow the "3+3" dose increment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-ILT3 CAR-T cells | Experimental | Biological: anti-ILT3 CAR-TAll subjects were intravenous administrated with anti-ILT3 CAR-T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients, aged ≥18 years or ≤70 years;
- Acute myeloid leukemia AML M4/M5 subtype was diagnosed according to Fab standard classification, confirmed by bone marrow IHC or ILT3-positive expression by flow cytometry in monocytes (primary and young monocytes in bone marrow ≥20%)
- Relapsed/refractory patients, whose conditions meet:
- Main organ functions meet the following conditions:
- ECOG physical status score 0-3.
Key exclusion criteria (16 listed)
- Pregnant or lactating women;
- HIV serological positive;
- Active bacterial, fungal or viral infections that are not controlled by treatment;
- Suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage or other serious cardiovascular and cerebrovascular diseases;
- History and concomitant 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 |
|---|---|---|
| anti-ILT3 CAR-TAutologous T cells genetically modified with anti-ILT3 CAR | Biological | Anti-ILT3 CAR-T cells |
Primary outcome
Rate of grade 3 or 4 treatment related adverse effects
Time frame: up to 24 weeks after first infusion
All the CAR-T treatment related adverse events，including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.
Implantation endpoint
Time frame: up to 2 years after first infusion
To assess the duration of CAR-positive T cells in circulation, the copy number of CAR DNA was measured at the preset follow-up time point. The time when the results of any two consecutive tests were negative, were recorded as the "implantation endpoint"
5 secondary outcomes
Disease specific response
Time frame: up to 2 years after first infusion
Overall survival
Time frame: up to 2 years after inclusion
Progress-free survival
Time frame: up to 2 years after inclusion
CAR-T residue
Time frame: up to 2 years after first infusion
Minimal residual disease (MRD)
Time frame: up to 2 years after first infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
Jianping Lan principal investigator
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-ILT3 CAR-T in people with AML M4 and AML M5, run by Carbiogene Therapeutics 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 14 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 23 Mar 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Lai Jin (+86-18458227035, hjdl188@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of grade 3 or 4 treatment related adverse effects (time frame: up to 24 weeks after first 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 23 Mar 2021.