Actively Recruiting
Clinical Study on the Safety and Initial Efficacy of BGT007 Cell Therapy in Patients With Recurrent/Metastatic Refractory Digestive Tract Tumors
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2023-10-27
14
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and initial effectiveness of BGT007 cell therapy in patients with recurrent, metastatic, or refractory digestive system tumors, including esophageal, gastric, pancreatic, or colorectal cancers. This early-phase exploratory trial aims to determine the best dose of BGT007 cells for safe and effective treatment by gradually increasing doses and monitoring patients closely. The study is conducted as a single-arm, open-label trial using an improved "3+3" dose escalation design. Participants receive a single intravenous infusion of BGT007 cells at one of five dose levels, ranging from 5.0 × 10^7 to 3.0 × 10^9 cells. The first two dose groups include one subject each, while the remaining three groups follow the traditional "3+3" dose escalation method. After the infusion on day 0, patients are observed for at least four weeks to monitor dose-limiting toxicities and safety. Dose escalation proceeds based on these observations. During the study, participants undergo regular assessments to monitor safety and treatment effects, including measuring dose-limiting toxicities from day 0 to day 28. Additional outcomes tracked over 12 months include maximum concentration (C max), time to reach maximum concentration (T max), objective response rate (ORR), and progression-free survival (PFS). The study duration and follow-up vary per participant, focusing on careful monitoring of safety and initial efficacy.
CONDITIONS
Brief 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 wax section within 3 years before consent.
- At least one measurable lesion per RECIST v1.1 solid tumor criteria.
- Recurrent, metastatic, or refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal) with failure or intolerance to second-line or higher standard treatment.
- Ability to establish vein access for blood collection without contraindications.
- Adequate organ and bone marrow function as defined by specified blood counts, liver, renal, and coagulation parameters.
- Toxic side effects from prior anti-tumor therapy at grade 1 or less (CTCAE 5.0).
- Use of effective medical contraception during the study and for 6 months after dosing; negative pregnancy test for women of reproductive age within 72 hours before dosing.
You will not qualify if you...
- Active central nervous system metastases unless stable after treatment.
- Positive for HIV, hepatitis B or C infection with specified viral loads.
- Mental illness preventing cooperation with treatment and evaluation.
- Severe autoimmune diseases or long-term immunosuppressant use.
- Active or uncontrolled infections needing systemic treatment within 14 days before enrollment.
- Unstable systemic diseases including serious heart conditions and uncontrolled hypertension.
- Dysfunction of major organs such as lung, brain, or kidney.
- Major surgery or severe trauma within 4 weeks before cell therapy or planned during the study.
- Recent systemic chemotherapy, immunotherapy, or targeted therapy within specified time frames before apheresis.
- History of other incurable malignant tumors within 3 years except certain skin or cervical cancers.
- Previous chimeric antigen receptor T-cell therapies within 6 months.
- Graft-versus-host disease.
- Need for systemic steroid therapy prior to screening or long-term use during treatment.
- Severe allergies or history of allergies.
- Need for anticoagulation therapy.
- Pregnant or breastfeeding women or planning pregnancy within 6 months for both sexes.
- Any other reasons deemed by researchers for exclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants receive a single intravenous infusion of BGT007 cells at one of five increasing dose levels.
1 infusion visit (in-person)
Duration - At least 4 weeks
Participants are observed for at least 4 weeks after cell infusion to monitor safety and dose-limiting toxicity.
Weekly visits for up to 4 weeks
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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