To hear about similar clinical trials, please enter your email below
Trial Title:
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
NCT ID:
NCT05538195
Condition:
Gastric Cancer
Colon Cancer
Rectal Cancer
Esophageal Cancer
Pancreatic Cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CEA-targeted CAR-T cells
Description:
Administration method: intravenous infusion； Subjects will receive conditioning therapy
by Fludarabine and Cyclophosphamide before cell infusion.
Arm group label:
Intravenous of CEA-targeted CAR-T
Intervention type:
Biological
Intervention name:
CEA-targeted CAR-T cells
Description:
Administration method: intraperitoneal injection；Subjects will receive conditioning
therapy by Fludarabine and Cyclophosphamide before cell infusion.
Arm group label:
intraperitoneal injection of CEA-targeted CAR-T
Summary:
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study,
aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and
to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The
pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients
with CEA-positive advanced malignancies were obtained and the recommended dose and
infusion schedule.
Detailed description:
According to the different infusion methods, it is divided into two subgroups:
intravenous infusion and local infusion through the peritoneal cavity. Each subgroup
includes a dose exploration stage (Part A) and a dose expansion stage (Part B). 3
patients were explored, starting from the low-dose group, and in the dose expansion
phase, the safety and efficacy were further verified according to the safe recommended
dose obtained in the dose exploration phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old, male or female;
2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or
pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and
pancreatic cancer;
3. After receiving at least second-line standard treatment failure (disease progression
or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of
effective treatment methods;
4. Immunohistochemical staining of tumor samples within 3 months confirmed that the
tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); , the
positive rate ≥ 10%), the serum CEA of the patient is required to exceed 10ug/L.
5. At least one assessable lesion according to RECIST 1.1 criteria;
6. ECOG score 0-2 points;
7. No serious mental disorder;
8. Unless otherwise specified, the function of the vital organs of the subject shall
meet the following conditions:
1. Blood routine: white blood cells>3.0×10^9/L, neutrophils>0.8×10^9/L,
lymphocytes cells>0.5×10^9/L, platelets>75×10^9/L, hemoglobin>80g/L;
2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and
no obvious abnormality was found on electrocardiogram;
3. Renal function: serum creatinine≤2.0×ULN;
4. Liver function: ALT and AST ≤3.0×ULN (for patients with liver tumor
infiltration, it can be relaxed to ≤5.0×ULN);
5. Total bilirubin≤3.0×ULN;
6. Oxygen saturation ≥95% in non-oxygen state.
9. Have apheresis or venous blood collection standards, and have no other
contraindications for cell collection;
10. Subjects agree to use reliable and effective contraceptive methods for contraception
within 1 year after signing the informed consent form to receiving CAR-T cell
infusion (excluding rhythm contraception);
11. The patients themselves or their guardians agree to participate in this clinical
trial and sign the ICF, indicating that they understand the purpose and procedures
of this clinical trial and are willing to participate in the research.
Exclusion Criteria:
1. Those who have central nervous system metastasis or meningeal metastasis at the time
of screening are judged by the investigator to be unsuitable for inclusion;
2. Participated in other clinical studies within 1 month before screening;
3. vaccinated with live attenuated vaccine within 4 weeks before screening;
4. Received the following anti-tumor treatments before screening: Received
chemotherapy, targeted therapy or other experimental drug treatments within 14 days
or at least 5 half-lives (whichever is shorter);
5. Active infection or uncontrollable infection requiring systemic treatment;
6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history
of gastrointestinal bleeding within 3 months;
7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor
therapy has not improved to the baseline level or ≤ grade 1;
8. Suffering from any of the following heart diseases:
1. New York Heart Association (NYHA) stage III or IV congestive heart failure;
2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months
before enrollment;
3. Clinically significant ventricular arrhythmia, or a history of unexplained
syncope (except those caused by vasovagal or dehydration);
4. History of severe non-ischemic cardiomyopathy;
9. Patients with active autoimmune disease, or other patients requiring long-term
immunosuppressive therapy;
10. Suffering from other uncured malignant tumors in the past 3 years or at the same
time, except cervical carcinoma in situ and basal cell carcinoma of the skin;
11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive
and peripheral blood hepatitis B virus (HBV) DNA titer test is greater than the
normal range; hepatitis C virus (HCV) antibody positive and peripheral blood
hepatitis C Virus (HCV) RNA test is greater than the normal range; human
immunodeficiency virus (HIV) antibody positive; syphilis test positive;
12. Women who are pregnant or breastfeeding;
13. Other investigators deem it unsuitable to participate in the research.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
He'nan Cancer Hospital
Address:
City:
Henan
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning Li, MD
Phone:
13526501903
Email:
lining97@126.com
Contact backup:
Last name:
Yijie Ma, MM
Phone:
15038279901
Email:
mayijie1987@126.com
Start date:
June 7, 2022
Completion date:
June 7, 2025
Lead sponsor:
Agency:
Chongqing Precision Biotech Co., Ltd
Agency class:
Industry
Source:
Chongqing Precision Biotech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538195
