CARNCT04692948
TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia
A study testing Chimeric antigen receptor T cells (car-t) 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 TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute… 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?
- Chimeric antigen receptor T cells (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
- 9 Dec 2019to Dec 2023
- 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 (including the cut-off value), and the gender was not limited;
- The expected survival time ≥ 12 weeks;
- ECOG score 0-2;
- After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;
- The liver and kidney function and cardiopulmonary function meet the following requirements:
- Creatinine ≤ 1.5 ULN;;
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- LVEF ≥ 45%;
- Blood oxygen saturation > 91%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
- Able to understand the trial and have signed the informed consent.
Who cannot join
- Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
- In addition to 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;
- The patients with HBV (HCV) positive and HBV (HCV) positive in peripheral blood were detected for HBV (HCV) positive Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: 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 planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
- Patients who had received car-t therapy or other gene modified cell therapy before screening;
- Subjects who were receiving systemic steroid therapy within 7 days before screening or who were judged by the researcher to need long-term systemic steroid therapy during the 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 screening;
- According to the judgment of the researchers, it does not conform to the condition of cell preparation;
- Other researchers think 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, +86 18963789012, wangxingbing@ustc.edu.cn
About this study
This is a clinical study of TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute Myeloid Leukemia.（TAA6 cell injection is a T cell targeting CD276 chimeric antigen receptor）
Read the detailed description
AML is a malignant disease of myeloid hematopoietic stem / progenitor cells and the most common hematological malignancy. It is characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. In recent years, due to the aging of the population, the incidence of AML and MDS has been on the rise. What is also troubling us is that the incidence of treatment-related MDS and AML in children and adolescents with Hodgkin's disease, sarcoma, breast and testicular tumors, lymphoma and other patients who survive after treatment is also gradually increasing. Occupational exposure such as ionizing radiation and benzene and petrochemical are also related to the incidence of AML.
Car t therapy is the most effective and widely used in the treatment of all. B7-H3, also known as cd276, was first discovered in 2001. It is mainly expressed on the cell surface, such as activated dendritic cells, monocytes, T cells, B cells and NK cells. Studies have shown that B7-H3 can stimulate the expansion and killing of T cells, and may selectively stimulate the signal receptor of T cells. It is a promising target for AML immunotherapy.
- Conditions
- CAR, Acute Myeloid Leukemia
- Being tested
- Chimeric antigen receptor T cells (car-t)
- 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.
Chimeric antigen receptor T cells (car-t)Other
Also called TAA6 cell injection
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 |
|---|---|---|
| TAA6 cell injection | Experimental | Drug: TAA6 cell injection（Targeting CD276 autologous chimeric antigen receptor T cells）
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. Receives: Other: Chimeric antigen receptor T cells (car-t) |
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 posted5 Jan 2021
- Study start9 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (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
- NCT04692948
- Sponsor's protocol ID
- PG-CART-TAA6-001
- Status last verified
- Mar 2021
- First submitted
- 28 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAA6 Cell Injection In The Treatment of Patients With Relapsed / Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04692948
- Acronym / sponsor ID
- PG-CART-TAA6-001
- 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
- 9 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Jan 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 TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute Myeloid Leukemia.（TAA6 cell injection is a T cell targeting CD276 chimeric antigen receptor）
Detailed description
AML is a malignant disease of myeloid hematopoietic stem / progenitor cells and the most common hematological malignancy. It is characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. In recent years, due to the aging of the population, the incidence of AML and MDS has been on the rise. What is also troubling us is that the incidence of treatment-related MDS and AML in children and adolescents with Hodgkin's disease, sarcoma, breast and testicular tumors, lymphoma and other patients who survive after treatment is also gradually increasing. Occupational exposure such as ionizing radiation and benzene and petrochemical are also related to the incidence of AML.
Car t therapy is the most effective and widely used in the treatment of all. B7-H3, also known as cd276, was first discovered in 2001. It is mainly expressed on the cell surface, such as activated dendritic cells, monocytes, T cells, B cells and NK cells. Studies have shown that B7-H3 can stimulate the expansion and killing of T cells, and may selectively stimulate the signal receptor of T cells. It is a promising target for AML immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAA6 cell injection | Experimental | Other: Chimeric antigen receptor T cells (car-t)Drug: TAA6 cell injection（Targeting CD276 autologous chimeric antigen receptor T cells） 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 (including the cut-off value), and the gender was not limited;
- The expected survival time ≥ 12 weeks;
- ECOG score 0-2;
- After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;
- The liver and kidney function and cardiopulmonary function meet the following requirements:
Key exclusion criteria (13 listed)
- Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy;
- In addition to 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;
- The patients with HBV (HCV) positive and HBV (HCV) positive in peripheral blood were detected for HBV (HCV) positive Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: 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 |
|---|---|---|
| Chimeric antigen receptor T cells (car-t)Also: TAA6 cell injectionChimeric 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. | Other | TAA6 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 8 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.
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 Chimeric antigen receptor T cells (car-t) 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 10 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 8 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.
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 8 Mar 2021.