Status:
NOT_YET_RECRUITING
CART Therapy in Digestive System Tumors
Lead Sponsor:
Innovative Cellular Therapeutics Co., Ltd.
Collaborating Sponsors:
Anhui Provincial Cancer Hospital
Conditions:
Malignant Neoplasms of Digestive Organs
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Chimeric Antigen Receptor T Cells (CART) Therapy in GUYC2C postive Digestive system tumors, include colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, adenocarcinoma of esophagus, can...
Detailed Description
The primary objective of phase 1 is to evaluate the safety of CART regimens. The primary objective of phase 2 is to evaluate the efficacy of CART, as measured by objective response rate in subjects wi...
Eligibility Criteria
Inclusion
- Aged between 18 and 70;
- Positive expression of immunohistochemical (IHC) assay targets in a laboratory approved by the partner;
- Pathology confirmed digestive tract tumor;
- Patients who have failed or relapsed after at least the first and second line standard treatment, and patients who are intolerant to or voluntarily give up the standardized treatment;
- At least one extracranial measurable lesion according to RECIST1.1 or EORTC or PERCIST;
- Expected survival ≥90 days;
- The main organs are functioning normally, i.e. they meet the following criteria:
- ECOG physical condition score is 0\~1 or KPS score is \>70;
- serum test criteria were as follows: HB≥90g/L (no blood transfusion within 14 days), ANC≥ 1.5 x 10\^9/L, PLT≥80 x 10\^9/L, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×ULN (upper limit of normal value).
- Biochemical examination shall meet the following standards: TBIL≤ 1.5x ULN (upper limit of normal value); ALT and AST≤ 2.5x ULN; ALT and AST≤5xULN in case of liver metastasis; Serum Cr≤1xULN, endogenous creatinine clearance rate \>50 ml/min (Cockcroft-Gault formula);
- cardiac ejection fraction \>55%;
- No hemorrhagic disease or coagulation disorder;
- No allergy to the developer;
- Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use an appropriate method of contraception during and 8 weeks after the last dose of CART (women who have undergone sterilization or have been postmenopausal for at least 2 years may be considered sterile);
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion
- T cell transduction efficiency \<5% or T cell amplification \< 2 times after culture;
- Participated in other drug clinical trials within 4 weeks before the start of the study;
- Patients with hypertension and unable to obtain good control by single antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure b\> 90 mmHg, the specific conditions shall be evaluated by the researchers) have myocardial ischemia or infarction of grade I or above, arrhythmia of grade I or above (including QT interval ≥ 440ms) or cardiac insufficiency;
- A wound or fracture in the chest or other area that has not healed for a long time;
- Has a history of substance abuse and is unable to quit or has a history of mental disorders;
- Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.;
- Fungus, bacteria, virus or other infection that cannot be controlled or requires antibiotic treatment. The presence of a simple urinary tract infection and uncomplicated bacterial pharyngitis is permitted after consultation with a medical supervisor;
- For subjects who have used chemotherapy before, according to NCI-CTCAE 4.0, there is grade ≥2 hematological toxicity or grade ≥3 non-hematological toxicity at the time of enrollment;
- A known history of HIV, or a positive nucleic acid test for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive);
- The presence of any indwered catheter or drainage tube (e.g., bile drainage tube or pleural/peritoneal/pericardial catheter). The use of specialized central venous catheters was permitted (the influence of fistula, percutaneous nephrostomy, and indwsed Foley catheters in colorectal cancer patients was considered by the investigators);
- Brain metastases; A history or medical condition of CNS, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
- metastases to brain;
- Significant immunodeficiency;
- The major therapeutic drugs in this study (including fludalabine, cyclophosphamide, sodium meth, and tozumab and anti-infective drugs used to prevent and treat CRS) have a history of severe hypersensitivity reaction;
- History of deep vein thrombosis or pulmonary embolism 6 months before enrollment;
- A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in injury to the terminal organs or that requires systemic immunosuppressive/disease-modulating drugs in the past 2 years;
- Any disease that may interfere with the evaluation of the safety or efficacy of the study treatment.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04780529
Start Date
March 1 2021
End Date
March 1 2026
Last Update
March 3 2021
Active Locations (1)
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1
Anhui provincial cancer hospital
Hefei, Anhui, China