Acute Myeloid Leukemia RefractoryPhase 1/2NCT05488132
Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
A Phase 1/2 study testing anti-siglec-6 CAR-T cell therapy in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia, in Relapse, run by Xuzhou Medical University at 1 site in China.
Trial summary
To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse
- What is being tested?
- anti-siglec-6 CAR-T cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- 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;
- At the age of 18-70 years old;
- Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- 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: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 is positive; HCV 、HIV or 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, 1 recruiting
- Recruiting
Kailin Xu
Xuzhou, Jiangsu, 221000
Kailin Xu, M.D., Ph.D., 86-516-85802007
About this study
Official title: Application of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Read the detailed description
Sialic acid-binding immunoglobulin-like lectins (Siglec) are a class of classical immunoglobulin-like lectins. Studies have shown that Siglec-6 is commonly expressed in AML but not detected on normal hematopoietic stem and progenitor cells (HSC/P). In vitro experiments revealed that anti-Siglec-6 CAR-T cell treatment did not affect the viability or lineage differentiation in colony-forming assays. These data suggest that anti-SigLlec-6 is an ideal target with great potential for treating acute myeloid leukemia.
- Being tested
- anti-siglec-6 CAR-T cell therapy
- 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.
anti-siglec-6 CAR-T cell therapyDrug
Enrolled patients will receive prespecified dose of autologous CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| anti-siglec-6 CAR-T cell therapy | Experimental | anti-siglec-6 CAR-T cell therapy Receives: Drug: anti-siglec-6 CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after T cell infusion
Secondary outcomes (4)
MRD negative overall response rate (MRD- ORR)
Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment
Measured: 3 months
Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Event-free survival (EFS)
Assessment of EFS at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Overall survival (OS)
Assessment of OS at Month 6, 12, 18 and 24
Measured: Time Frame: Month 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia RefractoryStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
- Investigators
- Kailin Xu, M.D., Ph.D., Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488132
- Sponsor's protocol ID
- XYFY2022-KL119-01
- Status last verified
- Mar 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
- ClinicalTrials.gov ID
- NCT05488132
- Acronym / sponsor ID
- XYFY2022-KL119-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Aug 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.
To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Detailed description
Sialic acid-binding immunoglobulin-like lectins (Siglec) are a class of classical immunoglobulin-like lectins. Studies have shown that Siglec-6 is commonly expressed in AML but not detected on normal hematopoietic stem and progenitor cells (HSC/P). In vitro experiments revealed that anti-Siglec-6 CAR-T cell treatment did not affect the viability or lineage differentiation in colony-forming assays. These data suggest that anti-SigLlec-6 is an ideal target with great potential for treating 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 |
|---|---|---|
| anti-siglec-6 CAR-T cell therapy | Experimental | Drug: anti-siglec-6 CAR-T cell therapyanti-siglec-6 CAR-T cell therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
- At the age of 18-70 years old;
- Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- 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 is positive; HCV 、HIV or 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 |
|---|---|---|
| anti-siglec-6 CAR-T cell therapyEnrolled patients will receive prespecified dose of autologous CAR-T cells. | Drug | anti-siglec-6 CAR-T cell therapy |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: Baseline up to 28 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
4 secondary outcomes
MRD negative overall response rate (MRD- ORR)
Time frame: 3 months
Overall response rate (ORR)
Time frame: Month 6, 12, 18 and 24
Event-free survival (EFS)
Time frame: Month 6, 12, 18 and 24
Overall survival (OS)
Time frame: Time Frame: Month 6, 12, 18 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Kailin Xu, M.D., Ph.D. principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anti-siglec-6 CAR-T cell therapy in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia, in Relapse, run by Xuzhou Medical 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 8 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 4 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kailin Xu, M.D., Ph.D. (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: Baseline up to 28 days after T cell 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 4 Aug 2022.