Actively Recruiting
BGT007H 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 BGT007H injection in the treatment of recurrent/metastatic/refractory digestive system tumors.
CONDITIONS
Official Title
BGT007H 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 and female
- Expected survival of at least 3 months
- Eastern Cancer Collaboration (ECOG) performance status 0-1
- Positive target protein test from biopsy or pathology specimen within 3 years
- At least one measurable lesion according to RECIST v1.1 criteria
- Recurrent, metastatic, or refractory digestive tract tumors with prior second-line or above treatment failure or intolerance
- Ability to establish vein access for blood collection and no contraindications for blood cell separation
- Adequate organ and bone marrow function as defined by specific blood counts and liver, kidney, and coagulation function
- Toxic side effects from previous anti-tumor therapy are grade 1 or lower (CTCAE 5.0)
- Fertile subjects must use effective contraception during the study and for 6 months after dosing
- Negative pregnancy test within 72 hours before first dose for females of reproductive age
You will not qualify if you...
- Active central nervous system metastases unless stable after treatment
- Positive for HIV, HBsAg, HBV DNA >1000 cps/ml, HCV antibody and RNA
- Mental illness preventing cooperation with treatment and evaluation
- Severe autoimmune diseases and long-term immunosuppressant use
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
- Unstable systemic diseases including recent heart or cerebral events, severe arrhythmias, uncontrolled hypertension
- Dysfunction of lung, brain, or kidney
- Major surgery or severe trauma within 4 weeks before cell therapy or planned during study
- Recent systemic chemotherapy, immunotherapy, or targeted therapy within 1-2 weeks before apheresis or within 5 half-lives
- Other malignant tumors not cured within 3 years except certain skin and cervical cancers
- Received chimeric antigen receptor T-cell therapy within 6 months
- Graft-versus-host disease
- Current or prior long-term systemic steroid use, or systemic steroids within 72 hours before cell transfusion
- Severe allergies or allergy history
- Need for anticoagulation therapy
- Pregnant or breastfeeding women or planning pregnancy within 6 months
- Other reasons deemed by researchers for exclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 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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