Actively Recruiting
A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-08
36
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of CEA-targeted CAR-T cell therapy in patients with advanced or metastatic solid tumors that test positive for CEA, including cancers of the colon, esophagus, stomach, pancreas, lung, breast, and bile ducts. This phase I study aims to determine the maximum tolerated dose and the recommended dose for phase II treatment. The study is open-label and non-randomized, involving two groups: one receiving intravenous infusion and the other intraperitoneal injection of CEA-targeted CAR-T cells. Each group has four dose levels, with about 12 subjects per group undergoing a dose-escalation 3+3 design. Before CAR-T cell infusion, patients receive lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide. Participants will be monitored closely for adverse events and safety during the first 28 days after infusion. Researchers will also assess several outcomes over months to years, including tumor response rates, duration of response, overall survival, progression-free survival, and CAR-T cell dynamics. The total follow-up may last up to two years, with regular evaluations including imaging and laboratory tests to measure effectiveness and cell behavior.
CONDITIONS
Brief Title
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic 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 confirmed by histology or pathology, mainly colorectal, esophageal, gastric, and pancreatic cancers
- Have failed or are intolerant to at least second-line standard treatments such as surgery, chemotherapy, or radiotherapy
- Tumor confirmed CEA positive by immunohistochemical staining within 3 months, with positive rate ≥ 10% and serum CEA level above 10 ug/L
- At least one lesion measurable by RECIST 1.1 criteria
- ECOG performance status of 0-2
- No serious mental disorders
- Adequate vital organ function including blood counts, cardiac function, renal and liver function, and oxygen saturation
- Eligible for apheresis or venous blood collection with no contraindications
- Agree to use effective contraception for 1 year after CAR-T infusion
- Provide informed consent acknowledging understanding and willingness to participate
You will not qualify if you...
- Central nervous system or meningeal metastasis deemed unsuitable by investigator
- Participation in other clinical trials within 1 month before screening
- Vaccination with live attenuated vaccines within 4 weeks before screening
- Received chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives before screening
- Active or uncontrolled infections requiring systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or history of bleeding within 3 months
- Persistent toxicity from prior treatments above grade 1 except alopecia or peripheral neuropathy
- Severe heart diseases such as NYHA stage III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated malignancies within past 3 years except certain skin or cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis above normal ranges
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by investigators
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 lymphodepletion with Fludarabine and Cyclophosphamide followed by infusion or injection of CEA-targeted CAR-T cells depending on their assigned group.
Multiple visits during treatment period including infusion/injection and monitoring visits
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and long-term outcomes after CAR-T cell therapy.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
F
Fei Li, 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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