Actively Recruiting
Exploratory Study of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced or Metastatic Solid Tumors
Led by China Medical University, China · Updated on 2024-02-21
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
China Medical University, China
Lead Sponsor
S
Shanghai First Song Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating anti-CEA-CAR-T cells in patients with locally advanced or metastatic solid tumors that express the CEA protein. This exploratory Phase 1 study aims to assess the safety and potential effectiveness of this cellular therapy in patients whose conventional treatments have been ineffective or are not suitable. The study includes patients with certain digestive system tumors and other solid tumors showing high CEA expression. The treatment involves a single intravenous infusion of anti-CEA-CAR-T cells, with doses based on the number of CAR-positive cells per kilogram of body weight. The dosing follows a 3+3 escalation design with three dose levels. Patients receive lymphocyte clearance therapy with cyclophosphamide and fludarabine before the CAR-T cell infusion. Additional infusions may be given at the investigator's discretion. The study includes a screening period, collection of mononuclear cells, possible bridging therapy, and pretreatment before infusion. Participants will be closely monitored for dose-limiting toxicity within 21 days after infusion, and objective response rates will be evaluated at set intervals up to 12 months. Assessments include physical exams, laboratory tests, and imaging to measure tumor size and treatment effects. Safety and treatment responses are recorded throughout the study, which lasts until at least one year after treatment. The study is open-label and conducted at a single center.
CONDITIONS
Brief Title
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent and voluntarily participate
- Age 18 to under 70 years, any gender
- Locally advanced or metastatic solid tumors with high CEA expression (intensity 2+ on ≥50% of tumor area)
- Histologically confirmed solid tumors, mainly digestive system cancers, with ineffective or unsuitable conventional treatment
- At least one measurable lesion per RECIST v1.1, max diameter ≤ 6 cm
- Expected survival of at least 12 weeks
- ECOG performance status of 0 to 2
- Adequate blood counts without recent transfusions or growth factors
- Adequate liver function within specified limits
- Adequate kidney function with creatinine clearance ≥ 50 mL/min
- Left ventricular ejection fraction (LVEF) ≥ 50%
- No difficulty breathing at rest or low oxygen saturation
- Suitable intravenous access for blood cell collection
- Negative pregnancy test for women of childbearing age and agreement to use contraception until 6 months post last dose
You will not qualify if you...
- Prior use of any CAR-T or genetically modified T cell therapy
- Waiting for or history of organ or stem cell transplantation
- Active or uncontrolled infections including tuberculosis
- Positive for HBV, HCV, syphilis, or HIV infections
- Low blood sodium (<125 mmol/L) or potassium (<3.5 mmol/L) not corrected
- Liver tumor involvement ≥ 50%
- Recent use of systemic steroids or certain immunotherapies before treatment
- Recent antibody therapy or radiotherapy except limited palliative
- Other malignancies within 5 years except certain controlled cancers
- Active ulcers or gastrointestinal bleeding
- CNS tumors or diseases affecting safety
- Uncontrolled heart, lung, or severe systemic diseases
- Recent major surgery or trauma not recovered
- Allergy or intolerance to study or preconditioning drugs
- Participation in other interventional trials within 1 month
- Pregnant or lactating women
- Unwilling or unable to comply with study protocols
- Persons involved in study planning or execution
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 - 21 days within anti-CEA-CAR-T cell infusion
Participants receive lymphocyte clearance therapy followed by a single intravenous infusion of anti-CEA-CAR-T cells. Follow-up infusions may occur based on the investigator's decision.
1 infusion visit and additional visits as needed for follow-up infusions
Duration - Up to 12 months after infusion
Participants are monitored for objective response and safety at multiple time points after the anti-CEA-CAR-T cell infusion.
Visits at 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 12 months post-infusion
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical Univeristy
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
S
Shuhui Song, bachelor
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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