FLT3-positive Relapsed/Refractory Acute Myeloid LeukemiaEarly Phase 1NCT05432401
TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia
A Early Phase 1 study testing T cell injection targeting FLT3 chimeric antigen receptor in people with FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a single arm , open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia
- What is being tested?
- T cell injection targeting FLT3 chimeric antigen receptor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 9 Jun 2025
- 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
- Aged 18 to 70 years old (inclusive), male or female;
- Expected survival time ≥ 3 months;
- ECOG performance status of 0-2;
- A clear diagnosis of acute myeloid leukemia at screening and positive expression of FLT3 in tumor cells;
- Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment and meet any of the following criteria:
- After AML complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration;
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- Initial cases that failed after 2 courses of standard treatment;
- After CR, patients with relapse within 12 months after consolidation and intensive treatment;
- Patients who relapsed after 12 months but did not respond to conventional chemotherapy;
- 2 or more relapses; persistent extramedullary leukemia;
- Coagulation function, liver and kidney function, cardiopulmonary function meet the following requirements:
- Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time≤1.5 ULN;
- Creatinine≤1.5 ULN;
- Left ventricular ejection fraction≥50%, and no pericardial effusion was found on echocardiography, and no clinically significant abnormal bands were found on electrocardiography;
- Indoor baseline oxygen saturation>92%;
- Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltration or bile duct obstruction) as judged by the investigator, the indicators can be relaxed to ≤ 5 × ULN;
- Patients who can understand the trial and have signed informed consents.
Who cannot join
- Subjects with malignant tumors other than acute myeloid leukemia within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract infection);
- Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion;
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- Subjects who are receiving systemic steroid therapy within 7 days prior to screening or need long-term use of systemic steroid therapy during treatment as judged by the investigator (except for inhalation or topical use);
- Subjects who have participated in other clinical studies within 1 months prior to screening;
- Subjects who have evidence of central nervous system invasion at screening, such as tumor cells detected in cerebrospinal fluid or imaging suggesting central infiltration;
- Patients with graft-versus-host reaction and need to use immunosuppressants;
- Patients with a history of epilepsy or other central nervous system diseases;
- Patients with primary immunodeficiency disease;
- Conditions not eligible for cell preparation as judged by the investigator;
- Other conditions considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
Wuhan, Hubei, 430000
Danying Liao, MD, 15623011361, Dr_liaodanying@126.com
About this study
Official title: Clinical Study of TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia
This is a single arm , open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia. The secondary objectives are as follows: to evaluate the in vivo expansion and persistence of FLT3-targeted chimeric antigen receptor T (CAR-T) cells after injection of TAA05;to evaluate the proportion of FLT3-positive cells in peripheral blood after injection of TAA05;to preliminarily evaluate the efficacy of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia;to evaluate the immunogenicity of TAA05 injection;and to explore the applicable dose in the formal clinical phase.
Read the detailed description
Approximately 1 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD.
- Being tested
- T cell injection targeting FLT3 chimeric antigen receptor
- 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.
T cell injection targeting FLT3 chimeric antigen receptorBiological
Also called TAA05 Injection
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once.
| Study group | Role | What they receive |
|---|---|---|
| T cell injection targeting FLT3 chimeric antigen receptor | Experimental | The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once. Receives: Biological: T cell injection targeting FLT3 chimeric antigen receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose limiting toxicity
Measured: About 2 years
MTD
Maximum tolerated dose
Measured: About 2 years
Secondary outcomes (11)
Assessment of the safety after FLT3-targeted chimeric antigen receptor T cells infusion (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: About 2 years
Assessment of pharmacokinetic (about Cmax)
Assessment of the highest concentration (Cmax) of FLT3-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Measured: About 28 days
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of FLT3-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Measured: About 28 days
Assessment of pharmacokinetic (about AUC0-28d)
Assessment of the area under the curve AUC0-28d after administration.
Measured: About 28 days
Assessment of pharmacokinetic (about AUC0-90d)
Assessment of the area under the curve AUC0-90d after administration. Assessment of the area under the curve AUC0-90d after administration. Assessment of the area under the curve AUC0-90d after administration.
Measured: About 90 days
PD endpoints
The proportion and absolute value of FLT3-positive cells in peripheral blood at each time point; concentration levels of CAR-T-related serum cytokines such as CRP and IL-6.
Measured: About 2 years
To Evaluate Anti-tumour Activity (overall response rate)
Rate of participants who with lymphoma aquire complete response (CR) or partial response (PR) or those who with leukemia CR or CR with incomplete hematologic recovery (CRi).
Measured: About 3 months
To Evaluate Anti-tumour Activity (Overall Survival)
Defined as the time from start of FLT3 CAR-T cell therapy to death (due to any cause)
Measured: About 2 years
To Evaluate Anti-tumour Activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR , CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Measured: About 2 years
To Evaluate Anti-tumour Activity (Progression Free Survival)
Defined as the time from the start of FLT3 CAR-T cell therapy to the first disease progression or recurrence or death from any cause.
Measured: About 2 years
Immunogenicity endpoints
Positive rate of human anti-CAR antibody at each time point.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start9 Jun 2022
- Primary completion9 Jun 2023 (estimated)
- Study completion9 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FLT3-positive Relapsed/Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TAA05 Injection
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heng Mei, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432401
- Sponsor's protocol ID
- PG-pCART-TAA05-001
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 27 Jun 2022
- 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 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05432401
- Acronym / sponsor ID
- PG-pCART-TAA05-001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 9 Jun 2023 (estimated)
- Study completion
- 9 Jun 2025 (estimated)
- First posted
- 27 Jun 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 arm , open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia. The secondary objectives are as follows: to evaluate the in vivo expansion and persistence of FLT3-targeted chimeric antigen receptor T (CAR-T) cells after injection of TAA05;to evaluate the proportion of FLT3-positive cells in peripheral blood after injection of TAA05;to preliminarily evaluate the efficacy of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia;to evaluate the immunogenicity of TAA05 injection;and to explore the applicable dose in the formal clinical phase.
Detailed description
Approximately 1 sites are planned to be selected for the clinical trial. The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once. Dose escalation will follow 3 + 3 design and 3-6 subjects in each group will complete a single dose. Within the same dose group, the next subject will be administered after the previous subject has completed at least 14 days of safety observation. After the last subject in each dose group has completed the dose-limiting toxicity (DLT) assessment window of 28 days after single dose, the enrollment and treatment for the next dose group may be initiated after the Safety Review Committee (SRC) agrees to enter the next dose group based on clinical safety data assessment.
When DLT occurs in 1 of 3 subjects in a dose group, 3 additional subjects in the same dose group will be required (up to 6 subjects in the dose group have completed DLT assessment): if no DLT occurs in the additional 3 subjects, dose escalation will continue; if 1 of the 3 additional subjects experiences one DLT, dose escalation will be discontinued; if more than 1 of the 3 additional subjects experiences DLTs, dose escalation will be discontinued, and 3 additional subjects will be required to be enrolled at one lower dose level for DLT assessment. After the end of escalation for the maximum dose group, if no MTD is observed, the highest dose level is defined as the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TAA05 Injection
| Arm | Type | Receives |
|---|---|---|
| T cell injection targeting FLT3 chimeric antigen receptor | Experimental | Biological: T cell injection targeting FLT3 chimeric antigen receptorThe subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 to 70 years old (inclusive), male or female;
- Expected survival time ≥ 3 months;
- ECOG performance status of 0-2;
- A clear diagnosis of acute myeloid leukemia at screening and positive expression of FLT3 in tumor cells;
- Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment and meet any of the following criteria:
Key exclusion criteria (14 listed)
- Subjects with malignant tumors other than acute myeloid leukemia within 5 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical mastectomy;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; positive for hepatitis C virus (HCV) antibody and peripheral blood hepatitis C virus (HCV) RNA; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA test; positive for syphilis test;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days prior to screening, there are active or uncontrollable infections requiring systemic therapy (except for mild genitourinary infection and upper respiratory tract 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 |
|---|---|---|
| T cell injection targeting FLT3 chimeric antigen receptorAlso: TAA05 InjectionThe subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10^8, 2.0 × 10^8 and 4.0 × 10^8 CAR-T groups in order of sequence. And the subjects will be administered once. | Biological | T cell injection targeting FLT3 chimeric antigen receptor |
Primary outcome
DLT
Time frame: About 2 years
Dose limiting toxicity
MTD
Time frame: About 2 years
Maximum tolerated dose
11 secondary outcomes
Assessment of the safety after FLT3-targeted chimeric antigen receptor T cells infusion (Safety)
Time frame: About 2 years
Assessment of pharmacokinetic (about Cmax)
Time frame: About 28 days
Assessment of pharmacokinetic (about Tmax)
Time frame: About 28 days
Assessment of pharmacokinetic (about AUC0-28d)
Time frame: About 28 days
Assessment of pharmacokinetic (about AUC0-90d)
Time frame: About 90 days
PD endpoints
Time frame: About 2 years
To Evaluate Anti-tumour Activity (overall response rate)
Time frame: About 3 months
To Evaluate Anti-tumour Activity (Overall Survival)
Time frame: About 2 years
To Evaluate Anti-tumour Activity (duration of response)
Time frame: About 2 years
To Evaluate Anti-tumour Activity (Progression Free Survival)
Time frame: About 2 years
Immunogenicity endpoints
Time frame: About 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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.
Heng Mei, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 T cell injection targeting FLT3 chimeric antigen receptor in people with FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) 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 17 inclusion and 14 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 27 Jun 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?
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 Heng Mei, MD (13886160811, mayheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: About 2 years). 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 27 Jun 2022.