Actively Recruiting
Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Led by Sichuan University · Updated on 2024-11-19
29
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.
CONDITIONS
Official Title
Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years
- Diagnosed with advanced solid tumors such as gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or pancreatic adenocarcinoma
- Have received at least one standard systemic treatment with disease progression or cannot tolerate further treatment
- Tumor shows CLDN18.2-positive expression of at least 10% by IHC assay
- Estimated life expectancy more than 3 months
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Sufficient venous access for leukapheresis and no contraindications to the procedure
- Adequate blood counts, kidney, and liver function
- No serious autoimmune or immune deficiency diseases
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for 12 months after treatment
- Men must agree to use effective contraception and not donate sperm for 12 months after treatment
- Voluntary participation with informed consent signed
You will not qualify if you...
- Pregnant or breastfeeding women
- Active hepatitis B or C infection or HIV above normal limits
- Any uncontrolled active infection
- Clinically significant thyroid dysfunction
- Prior cellular therapies like CAR T, TCR, or tumor-infiltrating lymphocytes
- Allergic to immunotherapy drugs or preconditioning regimens
- Untreated central nervous system metastases or related conditions
- Significant heart conditions posing risk in the trial
- Recent unstable blood clots within 6 months
- Active autoimmune diseases or those needing immunosuppressive treatment
- Major surgery or injury within 4 weeks before leukapheresis or planned during study
- Second cancers within 5 years other than the targeted tumor
- Active ulcers or digestive tract bleeding
- Conditions that impair consent or compliance
- History or risk of digestive tract bleeding
- Any condition deemed unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yao Zeng
CONTACT
D
Dan Li, PhD.
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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