Actively Recruiting
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
Led by China Medical University, China · Updated on 2024-02-21
9
Participants Needed
1
Research Sites
149 weeks
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
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
CONDITIONS
Official 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 voluntarily sign informed consent forms
- Age 18 to less than 70 years, any gender
- Locally advanced or metastatic solid tumors with cytoplasmic or membranous CEA expression of 2+ intensity in at least 50% of tumor area
- Histologically confirmed solid tumors, primarily digestive system cancers, with ineffective, intolerant, or no effective conventional treatment
- At least one measurable lesion per RECIST v1.1 with maximum diameter not exceeding 6 cm
- Expected survival of at least 12 weeks
- ECOG performance status of 0 to 2
- Adequate hematologic function without recent blood transfusion or growth factor use: neutrophils ≥ 1.0 x 10^9/L; hemoglobin ≥ 80 g/L; platelets ≥ 75 x 10^9/L; lymphocytes ≥ 0.5 x 10^9/L
- Adequate liver function: total bilirubin ≤ 1.5 x ULN (excluding Gilbert's syndrome); AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastasis)
- Adequate renal function: creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Left ventricular ejection fraction ≥ 50%
- No breathing difficulty at rest and pulse oximetry > 90% on room air
- Suitable intravenous access for apheresis without contraindications
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during and for 6 months after the study
You will not qualify if you...
- Prior use of any CAR-T cell or genetically modified T cell therapies
- Waiting for organ transplant or history of allogeneic stem cell or organ transplantation
- Acute or uncontrolled active infections, including active tuberculosis
- Positive for hepatitis B (HBV antigen or DNA > 10^3 copies/mL), hepatitis C antibodies, syphilis antibodies, or HIV antibodies
- Hyponatremia (sodium <125 mmol/L) or hypokalemia (potassium <3.5 mmol/L) not corrected before study
- Liver tumor involvement ≥ 50% on imaging
- Recent use of systemic steroids within 14 days before apheresis or 72 hours before therapy (except inhaled steroids)
- Recent systemic sexualization or unresolved toxicity from prior antineoplastic therapy except tolerable events
- Antibody therapy or anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks before apheresis
- Immunostimulation or immunosuppressive therapy within 28 days before apheresis
- Radiotherapy within 28 days before apheresis except local palliative radiotherapy
- Other malignancies within 5 years except certain controlled cancers
- Active ulcers or gastrointestinal bleeding difficult to control
- History or presence of CNS tumors or diseases affecting safety
- Uncontrolled cardiovascular or respiratory diseases
- Active or past autoimmune diseases that may relapse except certain controlled conditions
- Serious systemic diseases or conditions affecting study compliance or safety
- Major surgery within 4 weeks before apheresis or during dose-limiting toxicity observation
- Allergies or intolerance to study drugs or symptomatic treatments
- Participation in other interventional trials within 1 month before study
- Pregnant or lactating women
- Unwilling or unable to use contraception if of childbearing potential
- Unable or unwilling to comply with study protocol
- Involvement in study planning or execution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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