Actively Recruiting
BGT007 Cells for the Treatment of Refractory Digestive System Tumors
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2023-10-27
14
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor
G
Guangzhou Bioresette Biomedical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BGT007 Cells for the Treatment of Refractory Digestive System Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent.
- Age 18 to 70 years, male or female.
- Expected survival of at least 3 months.
- Eastern Cancer Collaboration (ECOG) physical fitness score of 0 or 1.
- Positive target protein test from biopsy or pathological specimen within 3 years before consent.
- At least one measurable lesion based on RECIST v1.1 criteria.
- Diagnosis of recurrent/metastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) with prior failure or intolerance to second-line or higher standard treatment.
- Ability to establish vein access for blood collection without contraindications for blood cell separation.
- Adequate organ and bone marrow function as defined by specific blood counts, liver function, renal function, and coagulation parameters.
- Toxic side effects from previous anti-tumor therapy at grade 1 or less (CTCAE 5.0).
- Fertile subjects must use effective contraception during study and for 6 months after dosing; negative pregnancy test within 72 hours before first dose for women of reproductive age.
You will not qualify if you...
- Active central nervous system metastases unless stable after treatment.
- Positive for HIV, HBsAg, high HBV DNA, or active HCV infection.
- Mental illness preventing cooperation with treatment and evaluation.
- Severe autoimmune diseases requiring long-term immunosuppressants.
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Unstable systemic diseases including recent cardiovascular events, severe arrhythmias, or uncontrolled hypertension.
- Dysfunction of important organs such as lung, brain, or kidney.
- Major surgery or severe trauma within 4 weeks prior to cell therapy or planned during study.
- Recent chemotherapy, immunotherapy, or targeted therapy within 1-2 weeks before apheresis or within 5 half-lives.
- Other malignant tumors not cured or with disease-free survival less than specified periods.
- Previous CAR-T or TCR-T therapy within 6 months.
- Graft-versus-host disease.
- Need for systemic steroid therapy prior to screening or during treatment (except inhalation or topical use).
- Severe allergies or history of allergies.
- Requirement for anticoagulation therapy.
- Pregnant or breastfeeding women, or those planning pregnancy within 6 months.
- Other reasons determined by researchers preventing inclusion.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
he Affiliated Hospital of Xuzhou Medical University
Xuzhou, JangSu, China, 221000
Actively Recruiting
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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