Actively Recruiting
PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-05
100
Participants Needed
15
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
\*\*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.
CONDITIONS
Official Title
PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Expected survival of at least 3 months
- ECOG performance status score of 0 or 1
- Confirmed diagnosis of acute T-cell lymphoblastic leukemia/lymphoma (including early T-cell precursor subtype)
- Recurrent or refractory disease status
- Positive expression of CD7 on abnormal cells
- If only extramedullary lesions are present, those lesions must be measurable
- Adequate liver, kidney, heart, and lung function
- No severe mental disorders
- Ability to understand the study and provide signed informed consent
You will not qualify if you...
- Active or uncontrolled autoimmune diseases
- Presence of graft-versus-host disease (GvHD)
- History of other malignant tumors within past 5 years except certain treated cancers
- Positive tests for hepatitis B, hepatitis C, syphilis, or similar infections
- Severe heart disease
- Unstable systemic diseases as judged by investigator
- Active or uncontrolled infections requiring systemic treatment
- Pregnant or breastfeeding women, or plans to conceive within 2 years after infusion
- Prior CAR-T or gene-modified cell therapy before screening
- Participation in other clinical trials within 1 month before screening
- Central nervous system involvement at screening
- Any condition making cell preparation unsuitable
- Other investigator-determined factors making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230000
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
4
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China, 510000
Actively Recruiting
5
The First Hospital of Harbin
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
6
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
9
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
10
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
11
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
12
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
13
West China Hospital, Sichuan University (WCHSU)
Chengdu, Sichuan, China, 610000
Actively Recruiting
14
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
15
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
X
Xiaojun Huang, MD
CONTACT
M
Mingzhi Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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