Actively Recruiting
Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
Led by TCRCure Biopharma Ltd. · Updated on 2026-03-23
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
CONDITIONS
Official Title
Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily provide written informed consent.
- Aged 18-70 years inclusive.
- Life expectancy of at least 3 months.
- ECOG performance status of 0 or 1.
- Have failed or are unsuitable for standard therapy.
- Have at least one measurable lesion according to RECIST 1.1.
- Tumor confirmed ALPP-positive by immunohistochemistry.
- Adequate organ and bone marrow function.
- Use effective contraception if of childbearing potential.
- Have adequate venous access for leukapheresis.
You will not qualify if you...
- Have primary central nervous system malignancy or uncontrolled CNS metastases.
- Have had other malignancies within the past 5 years except treated non-melanoma skin cancer or carcinoma in situ.
- Have active autoimmune disease or history of autoimmune disease.
- Have immunodeficiency, including HIV infection.
- Have inherited or acquired bleeding disorders.
- Have clinically significant cardiovascular disease.
- Have active infections including tuberculosis, hepatitis B or C, or syphilis.
- Are pregnant or breastfeeding.
- Have history of refractory epilepsy, active gastrointestinal bleeding, or high risk of tumor bleeding.
- Have severe systemic or psychiatric illness.
- Have received prior cell or gene therapy.
- Have severe drug hypersensitivity history.
- Are assessed by investigator as unsuitable for trial participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Jinling Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
T
Tangfeng LV, 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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