A Clinical Trial of TAA06 Injection in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05190185|
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma, Lung Cancer, or Colorectal Cancer||Biological: TAA06 injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of TAA06 Injection in Advanced Solid Tumors|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
Experimental: TAA06 injection
T cell injection targeting B7-H3 chimeric antigen receptor
Biological: TAA06 injection
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be treated with 1×106~1×108 CAR-T/kg. And the subjects will be administered once.
- Assessment of the safety after B7-H3 chimeric antigen receptor T cells infusion (Safety) [ Time Frame: 3 months ]Incidence and treatment-relativity of adverse events assessed by NCI CTCAE v5.0.
- To evaluate anti-tumor activity (overall response rate) [ Time Frame: 6 months ]Rate of participants achieving a complete response (CR) or partial response (PR).
- To evaluate anti-tumor activity (disease control rate) [ Time Frame: 3 months ]Rate of participants achieving a complete response (CR) or partial response (PR) or stable disease (PD).
- To evaluate anti-tumor activity (duration of response) [ Time Frame: About 2 years ]Defined as the time from the first tumor assessment of CR or PR to the first assessment of disease progression (PD) or death from any cause.
- To evaluate anti-tumor activity (Progression Free Survival) [ Time Frame: About 2 years ]Defined as the time from the date of study enrollment to the time when the investigator judges that imaging disease progression or death from any cause occurs.
- To evaluate anti-tumor activity (overall survival) [ Time Frame: About 2 years ]Defined as the time from start of the random beginning to death (due to any cause).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- (1) Aged 18 to 70 years old (inclusive), male or female;
- (2) Expected survival time ≥ 12 weeks;
- (3) ECOG performance status of 0-1;
- (4) It is clearly diagnosed by pathology to be any of the following tumor types: malignant melanoma, lung cancer or colorectal cancer, and the positive rate of TAA06 expression in tumor tissues is ≥1% after immunohistochemical detection;
- (5) Subjects whose standard treatment methods are ineffective (eg: relapse after surgery, disease progress after treatment with chemotherapy, radiotherapy or targeted drugs);
- (6) According to the curative effect evaluation standard for solid tumors (RECIST 1.1), at least one measurable lesion (the longest diameter of the solid lesion ≥ 10mm, or the short diameter of the lymph node lesion ≥ 15mm);
- (7) The main organ function is normal (white blood cell count ≥3×109/L, neutrophil count ≥1.5×109/L, hemoglobin ≥8.5g/dL, platelet count ≥80×109/L, lymphocyte count at 1×109/L (inclusive) ~ 4×109/L (inclusive));
(8) Liver and kidney function, heart and lung function meet the following criteria:
- Urea (Urea) and serum creatinine≤1.5×ULN;
- Left ventricular ejection fraction ≥50%;
- Baseline blood oxygen saturation ≥ 94%;
- Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN;
- (9) The subjects or his legal representative can fully understand the significance and risks of this trial and has signed informed consents.
- (1) Subjects with a history of immunodeficiency or autoimmune diseases (including but not limited to rheumatoid joint disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); with graft-versus-host disease (GVHD) , Or those who need to use immunosuppressive agents;
- (2) Subjects with other type of malignant tumors within 5 years prior to screening;
- (3) 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 syphilis test;
- (4) 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;
- (5) Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- (6) 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);
- (7) Pregnant or lactating women, and female subjects who plan to become pregnant within 1 year after cell infusion or male subjects whose partners plan to become pregnant within 1 year after cell infusion;
- (8) Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- (9) 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);
- (10) Subjects with more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase;
- (11) Conditions not eligible for cell preparation as judged by the investigator;
- (12) Other conditions considered unsuitable for enrollment by the investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05190185
|Contact: Zhiyu Wang, Doctor||+86-138 3119 email@example.com|
|PersonGen BioTherapeutics(Suzhou) Co., Ltd.||Recruiting|
|Suzhou, Jiangsu, China, 215125|
|Contact: Huimin Meng, Doctor +86-18015580390 firstname.lastname@example.org|
|Responsible Party:||PersonGen BioTherapeutics (Suzhou) Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||January 13, 2022 Key Record Dates|
|Last Update Posted:||January 13, 2022|
|Last Verified:||December 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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