Acute Myeloid LeukemiaPhase 1/2NCT05023707
Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing anti-FLT3 CAR-T in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- anti-FLT3 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 30 Jun 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FLT3 positive relapsed/refractory acute myeloid leukemia
- Age 16-65 years.
- Left ventricular ejection fractions ≥ 0.5 by echocardiography
- Creatinine < 1.5x upper limit of normal.
- Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
- Total bilirubin ≤ 1.5x upper limit of normal
- Karnofsky performance status ≥ 60
- Expected survival time ≥ 3 months (according to investigator's judgement)
Who cannot join
- Patients are pregnant or lactating
- Uncontrolled active infection
- Grade III/IV cardiovascular disability according to the New York Heart
- Association Classification
- Active hepatitis B or hepatitis C infection
- Patients with HIV infection
- Patients with a history of seizure
- Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, Ph.D, 86-512677801856, xwtang1020@163.com
About this study
Official title: Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.
Read the detailed description
The patients will receive infusion of anti-FLT3 CAR T-cells targeting FLT3 to evaluate the safety and efficacy of anti-FLT3 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- anti-FLT3 CAR-T
- Keywords
- FLT3,CAR-T,AML
- 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-FLT3 CAR-TBiological
Single intravenous infusion of anti-FLT3 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T infusion | Experimental | FLT3 positive relapsed or refractory acute myeloid leukemia Receives: Biological: anti-FLT3 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Measured: 12 months
Secondary outcomes (3)
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0 x 109/L) or thrombocytopenia (<100 x 109/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Measured: 2 years
Event-free survival (EFS)
time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause
Measured: 2 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start31 Dec 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 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 LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second People's Hospital of Huai'an, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023707
- Sponsor's protocol ID
- 2021136
- Status last verified
- Jul 2021
- First submitted
- 10 Aug 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT05023707
- Acronym / sponsor ID
- 2021136
- Conditions
- Acute Myeloid Leukemia
- Keywords
- FLT3,CAR-T,AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second People's Hospital of Huai'an, PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Aug 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 is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.
Detailed description
The patients will receive infusion of anti-FLT3 CAR T-cells targeting FLT3 to evaluate the safety and efficacy of anti-FLT3 CAR T-Cells in relapsed or 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 |
|---|---|---|
| CAR-T infusion | Experimental | Biological: anti-FLT3 CAR-TFLT3 positive relapsed or refractory acute myeloid leukemia |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- FLT3 positive relapsed/refractory acute myeloid leukemia
- Age 16-65 years.
- Left ventricular ejection fractions ≥ 0.5 by echocardiography
- Creatinine < 1.5x upper limit of normal.
- Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
Key exclusion criteria (8 listed)
- Patients are pregnant or lactating
- Uncontrolled active infection
- Grade III/IV cardiovascular disability according to the New York Heart
- Association Classification
- Active hepatitis B or hepatitis C infection
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-FLT3 CAR-TSingle intravenous infusion of anti-FLT3 CAR-T cells | Biological | CAR-T infusion |
Primary outcome
Number of Adverse Events
Time frame: 12 months
Adverse events are evaluated with CTCAE V5.0
3 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
Event-free survival (EFS)
Time frame: 2 years
Cumulative incidence of relapse(CIR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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.
Xiaowen Tang, Ph.D principal investigator
The First Affiliated Hospital of Soochow 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-FLT3 CAR-T in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow 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 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: status not confirmed, as of the sponsor's last update on 30 Dec 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 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 Xiaowen Tang, Ph.D ((0086)51267781856, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 12 months). 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 30 Dec 2021.