\*\*Translation:\*\* This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells. Following lymphodepletion pretreatment, a single infusion of PA3-17 injection will be administered. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations. In addition to the baseline period, the treatment phase will involve efficacy assessments at 4 weeks, 2 months, 3 months, and every 3 months thereafter, up to 24 months post-cell infusion. Tumor assessments will continue until disease progression (PD), initiation of new antitumor treatment, death, unacceptable toxicity, investigator decision, or subject's voluntary withdrawal, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells, followed by lymphodepletion pretreatment and a single infusion of PA3-17 injection.
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China
RECRUITINGFacility Name: Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Hospital of Harbin
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITING...and 6 more locations
Efficacy
Three-month Objective Response Rate (ORR): Proportion of Composite Complete Response Rate (CRc: CR, CRh, CRi, MLFS) and PR
Time frame: Three months
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