CARNCT05017883
TAA05 Cell Injection in the Treatment of Recurrent / Refractory Acute Myeloid Leukemia
A study testing TAA05 cell injection in people with CAR and Acute Myeloid Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a clinical study of ytaa05 cell injection in the treatment of patients with recurrent / refractory acute myeloid leukemia.The purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent / refractory FLT3 positive acute myeloid leukemia.#TAA05 cell injection is a T… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CAR, Acute Myeloid Leukemia
- What is being tested?
- TAA05 cell injection
- 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
- 1 Jul 2021to Oct 2025
- Phase
- Interventional
- 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
- Age 18 ~ 70 years old (including boundary value), regardless of gender;
- Acute myeloid leukemia with FLT3 positive (positive rate ≥ 30%) verified by flow cytometry or immunohistochemistry;
- The expected survival time was more than 12 weeks;
- ECoG score 0-2;
- Refractory or relapse after standardized treatment;
- Liver and kidney function and cardiopulmonary function meet the following requirements:
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- Creatinine ≤ 1.5 ULN;
- Left ventricular ejection fraction ≥ 45%;
- Blood oxygen saturation > 91%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN；
- Understand the test and have signed the informed consent form.
Who cannot join
- Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents;
- Malignant tumors other than acute myeloid leukemia within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
- hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference range; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
- Unstable systemic diseases judged by the researcher: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
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- Pregnant or lactating women, female subjects who planned pregnancy within 1 year after cell reinfusion, or male subjects whose partners planned pregnancy within 1 year after cell reinfusion;
- Those who had received car-t therapy or other gene modified cell therapy before screening;
- Subjects who were receiving systemic steroid treatment within 7 days before screening or who were determined by the investigator to need long-term systemic steroid treatment during treatment (except inhalation or local use);
- Participated in other clinical studies within 3 months before screening;
- There was evidence of central nervous system invasion during subject screening;
- According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- Other researchers believe that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
xingbing wang, doctor, 13856007984, wangxingbing@ustc.edu.cn
About this study
This is a clinical study of ytaa05 cell injection in the treatment of patients with recurrent / refractory acute myeloid leukemia.The purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent / refractory FLT3 positive acute myeloid leukemia.#TAA05 cell injection is a T cell targeting FLT3 chimeric antigen receptor#
Read the detailed description
Acute myeloid leukemia (AML) is a hematological malignancy caused by abnormal differentiation and uncontrolled proliferation of hematopoietic progenitor cells. If AML is not given active treatment within one year after diagnosis, it will cause fatal infection, bleeding and organ infiltration due to abnormal proliferation of tumor cells. AML is one of the most common leukemia. About 3.8 patients in every 100000 people are in the higher incidence rate among people aged 65 and over, and 17.9 patients in every 100000 people. The cure rate of AML is about 35-40% in patients ≤ 60 years old and only 5-15% in patients over 60 years old. The survival of elderly patients who can not tolerate chemotherapy is frustrating, and the median survival time is only 5-10 months. In the past 20 to 30 years, the treatment of acute myeloid leukemia (AML) has made significant progress, so that about 80% of adult patients under the age of 55 can achieve complete remission. However, more than half of Cr patients will relapse, and the long-term survival rate is about 40%. Until the 1970s, diagnosis was only based on pathological and cytological examination of bone marrow and blood. The five-year survival rate was less than 15%.
CAR-T cells can recognize specific antigens in a non restricted manner of HLA and continuously activate T cells. FLT3 is a potential target of AML. Therefore, the construction of car-t cells that recognize human FLT3 molecule has high clinical value in the treatment of AML.
- Conditions
- CAR, Acute Myeloid Leukemia
- Being tested
- TAA05 cell injection
- 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.
TAA05 cell injectionDrug
Chimeric antigen receptor T cells (car-t)
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner,which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
| Study group | Role | What they receive |
|---|---|---|
| TAA05 cell injection | Experimental | TAA6 cell injection#Targeting FLT3 autologous chimeric antigen receptor T cells# Receives: Drug: TAA05 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR 3 ORR 3
3-month objective response rate
Measured: three months after CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jul 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Xingbing Wang, Principal investigator, No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017883
- Sponsor's protocol ID
- V2.0
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 4 Nov 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAA05 Cell Injection in the Treatment of Recurrent / Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05017883
- Acronym / sponsor ID
- V2.0
- Conditions
- CAR, Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Anhui Provincial Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 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 clinical study of ytaa05 cell injection in the treatment of patients with recurrent / refractory acute myeloid leukemia.The purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent / refractory FLT3 positive acute myeloid leukemia.#TAA05 cell injection is a T cell targeting FLT3 chimeric antigen receptor#
Detailed description
Acute myeloid leukemia (AML) is a hematological malignancy caused by abnormal differentiation and uncontrolled proliferation of hematopoietic progenitor cells. If AML is not given active treatment within one year after diagnosis, it will cause fatal infection, bleeding and organ infiltration due to abnormal proliferation of tumor cells. AML is one of the most common leukemia. About 3.8 patients in every 100000 people are in the higher incidence rate among people aged 65 and over, and 17.9 patients in every 100000 people. The cure rate of AML is about 35-40% in patients ≤ 60 years old and only 5-15% in patients over 60 years old. The survival of elderly patients who can not tolerate chemotherapy is frustrating, and the median survival time is only 5-10 months. In the past 20 to 30 years, the treatment of acute myeloid leukemia (AML) has made significant progress, so that about 80% of adult patients under the age of 55 can achieve complete remission. However, more than half of Cr patients will relapse, and the long-term survival rate is about 40%. Until the 1970s, diagnosis was only based on pathological and cytological examination of bone marrow and blood. The five-year survival rate was less than 15%.
CAR-T cells can recognize specific antigens in a non restricted manner of HLA and continuously activate T cells. FLT3 is a potential target of AML. Therefore, the construction of car-t cells that recognize human FLT3 molecule has high clinical value in the treatment of AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAA05 cell injection | Experimental | Drug: TAA05 cell injectionTAA6 cell injection#Targeting FLT3 autologous chimeric antigen receptor T cells# |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 ~ 70 years old (including boundary value), regardless of gender;
- Acute myeloid leukemia with FLT3 positive (positive rate ≥ 30%) verified by flow cytometry or immunohistochemistry;
- The expected survival time was more than 12 weeks;
- ECoG score 0-2;
- Refractory or relapse after standardized treatment;
Key exclusion criteria (13 listed)
- Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents;
- Malignant tumors other than acute myeloid leukemia within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
- hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference range; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
- Unstable systemic diseases judged by the researcher: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
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 |
|---|---|---|
| TAA05 cell injectionChimeric antigen receptor T cells (car-t) Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner,which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. | Drug | TAA05 cell injection |
Primary outcome
ORR 3 ORR 3
Time frame: three months after CAR-T cells infusion
3-month objective response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
Xingbing Wang principal investigator
No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAA05 cell injection in people with CAR and 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 11 inclusion and 13 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 Nov 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.
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 Xingbing Wang (13856007984, wangxingbing@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR 3 ORR 3 (time frame: three months after CAR-T cells 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 Nov 2021.