Actively Recruiting
Chimeric Antigen Receptor T Lymphocytes (CAR-T) Targeting CEA for CEA Positive Advanced Malignant Solid Tumors Clinical Study
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-13
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
F
First Affiliated Hospital of Wannan Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CEA-targeted Chimeric Antigen Receptor T (CAR-T) cell therapies in patients with CEA-positive advanced malignant solid tumors. This open-label, phase 1 study focuses on cancers such as colorectal, esophageal, gastric, pancreatic, breast, lung, and cholangiocarcinoma that have shown resistance or intolerance to at least second-line standard treatments. The main goal is to identify the recommended dose and infusion schedule while monitoring treatment safety. The study divides participants into two groups based on the method of CAR-T cell delivery: intravenous infusion and intraperitoneal injection. Each group undergoes a dose exploration phase starting with low doses, followed by a dose expansion phase to confirm safety and treatment effects at the recommended doses. Before receiving CAR-T cell infusions, participants are given conditioning therapy with fludarabine and cyclophosphamide. During the study, participants will have regular assessments including monitoring for treatment-related side effects within the first month and evaluating disease control rates over three months. Researchers will also study how the CAR-T cells behave in the body by measuring pharmacokinetic and pharmacodynamic parameters. Overall, the trial lasts through these phases with close safety and effectiveness monitoring to support dose recommendations and treatment planning.
CONDITIONS
Brief Title
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with advanced, metastatic, or recurrent malignant tumors such as colorectal, esophageal, gastric, or pancreatic cancer confirmed by histology or pathology
- Have failed at least second-line standard treatments due to disease progression or intolerance
- Tumor is CEA positive with at least 10% positive membrane staining confirmed within 3 months, and serum CEA level above 10 ug/L
- At least one measurable lesion according to RECIST 1.1 criteria (extranodal lesions length diameter
- ECOG performance status 0 to 2
- No serious mental disorders
- Adequate organ function including blood, heart, kidney, liver, and oxygen saturation as specified
- Meet standards for blood or apheresis collection without contraindications
- Agree to use effective contraception for 1 year after CAR-T cell infusion
- Provide informed consent and agree to participate in the clinical trial
You will not qualify if you...
- Presence of central nervous system or meningeal metastases deemed unsuitable
- Participation in other clinical studies within 1 month before screening
- Vaccination with live attenuated vaccine within 4 weeks before screening
- Recent chemotherapy, targeted, or experimental treatments within 14 days or 5 half-lives
- Active or uncontrolled infections requiring systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or recent history of gastrointestinal bleeding within 3 months
- Large uncontrolled fluid buildup in body cavities
- Unresolved toxicity from previous anti-tumor therapies above grade 1 (except alopecia or peripheral neuropathy)
- Heart diseases including severe heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune disease or need for long-term immunosuppression
- Other untreated malignant tumors within past 3 years except certain skin or cervical cancers
- Positive tests for hepatitis B or C virus, HIV, or syphilis beyond normal ranges
- Pregnant or breastfeeding women
- Any condition the investigator judges unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive conditioning therapy with ludarabine and cyclophosphamide followed by infusion of CEA-targeted CAR-T cells either intravenously or by intraperitoneal injection. This includes a dose exploration stage and a dose expansion stage to determine and verify the recommended dose and infusion regimen.
1 baseline visit and multiple visits during treatment
Duration - 3 months
Participants are monitored for safety, treatment-associated adverse events, and disease control rates for up to 3 months after treatment.
Weekly visits for up to 3 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
Research Team
L
lili Sheng, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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