BGT007 Cells for the Treatment of Refractory Digestive System Tumors

Recruiting now · Early Phase 1

Conditions studied: Gastrointestinal Cancer

In brief

This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007 injection in the treatment of recurrent/metastatic/refractory digestive system tumors

Key facts

Study ID

NCT06104241

Run by

The Affiliated Hospital of Xuzhou Medical University

People needed

14

Starts

2023-10-22

Expected to finish

2027-10-20

Last updated by the study team

2023-10-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily sign a written informed consent.
• Age ≥18 years old, ≤70 years old, male and female.
• Expected survival ≥ 3 months.
• The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1.
• Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent): Target protein test is positive.
• At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria.
• Patients with recurrent/metastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance.
• It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation.
• having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10\^9/L Platelet count (PLT) ≥80×10\^9/L Hemoglobin concentration ≥90g/L Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL/min Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN
• Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0).
• During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result are negative.

You may not qualify if…

• Active central nervous system metastases (except those stable after treatment).
• HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive.
• Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation.
• Subjects with severe autoimmune diseases and long-term use of immunosuppressants.
• Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment.
• Any unstable systemic disease (including but not limited to):
• Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association [NYHA] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100 mmHg).
• dysfunction of important organs such as lung, brain and kidney.
• The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy or is expected to undergo major surgery during the study period.
• Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to an apheresis or within 5 half-lives, whichever is shorter.
• The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years.
• Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months.
• Graft-versus-host disease (GVHD).
• Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use).
• Severe allergies or history of allergies.
• Subjects requiring anticoagulation therapy.
• Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)
• Researchers believe that there are other reasons for not being included in the treatment.

Where it is running

• he Affiliated Hospital of Xuzhou Medical University — Xuzhou, JangSu, China (enrolling)

Full record on ClinicalTrials.gov

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