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New treatment option for Gastrointestinal Cancer
Official title BGT007 Cells for the Treatment of Refractory Digestive System Tumors
ClinicalTrials.gov ID: NCT06104241
What this study is testing
What is BGT007 Injection?
BGT007 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastrointestinal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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.
You likely can't join 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 how well it works evaluation.
- people 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...
See the full eligibility criteria
- 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: people...
- 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 people (both male and female) must use effective medical contraception. For female people of reproductive age, a pregnancy test should be...
- 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 how well it works evaluation.
- people 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)...
- 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...
- 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...
- Severe allergies or history of allergies.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xuzhou, JangSu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xuzhou, JangSu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.