Actively Recruiting
Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With Relapsed/Refractory Pancreatic Cancer
Led by RenJi Hospital · Updated on 2024-06-27
12
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.
CONDITIONS
Official Title
Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With Relapsed/Refractory Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign an informed consent form
- Age 18 to 75 years, any gender
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Able to provide a pathological paraffin section for testing from within 3 years
- At least one measurable tumor lesion by CT or MRI meeting size requirements
- Advanced pancreatic cancer confirmed by histology or cytology, with progression after second-line or later treatment, intolerance to standard treatment, or no available standard treatment
- Able to undergo apheresis or venous blood collection and no contraindications to blood cell separation
- Adequate organ and bone marrow function as defined by specific blood counts and liver, kidney, and coagulation parameters
- Use effective contraception during the study and for 6 months after if of childbearing potential
- Negative pregnancy test within 72 hours before first dosing for females of childbearing potential
You will not qualify if you...
- Active central nervous system metastasis unless treated and stable
- Positive for HIV, active hepatitis B or C infection, or positive syphilis test
- Mental or psychological disorders preventing cooperation with the study
- Severe autoimmune diseases requiring long-term immunosuppressants
- Active or uncontrolled infection within 14 days before enrollment
- Unstable systemic diseases including recent stroke, heart attack, severe heart failure, severe arrhythmia, or uncontrolled hypertension
- Dysfunction of important organs such as lungs, brain, or kidneys
- Recent major surgery or severe trauma within 4 weeks before cell therapy
- Received systemic chemotherapy, immunotherapy, or targeted therapy within 1-2 weeks or 5 half-lives before apheresis
- Received CAR-T or TCR-T therapy within the past 6 months
- Severe allergies or history of allergies
- Requires anticoagulant therapy
- Pregnant or breastfeeding, or planning pregnancy within 6 months
- Any other reason deemed by the investigator to prevent study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
X
Xiuqi Wu, Doctorate
CONTACT
J
Jiujie Cui, Doctorate
CONTACT
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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