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
|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).
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 firstname.lastname@example.org|
|PersonGen BioTherapeutics(Suzhou) Co., Ltd.||Recruiting|
|Suzhou, Jiangsu, China, 215125|
|Contact: Huimin Meng, Doctor +86-18015580390 email@example.com|