BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age17-75
SponsorBioSyngen Pte Ltd
About this trial
This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 \^ 8 3 cases, Group B: 6.0X10 \^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1: Voluntarily sign a written informed consent form;
2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
3: Expected survival period ≥ 3 months;
4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
Disqualifiers
1: Active central nervous system metastases (excluding those that have been treated and stabilized);
2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;
3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
Trial design
Design model
Single group
Treatments tested in this trial
Group A
Biological/VaccineBGT007 3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled
Group B
Biological/VaccineBGT007 6.0×10\^8cells,Intravenous infusion，6 subject is planned to be enrolled
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: BGT007Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicity (DLT)
DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BGT007 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade 4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)
Time frame
From the infusion (Day 0) to Day 282
Maximum Tolerated Dose(MTD)
The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BGT007 administration and completed DLT observation)
Time frame
From the infusion (Day 0) to Day 28Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
BioSyngen Pte Ltd
Lead sponsor
South China Hospital of Shenzhen University
Collaborator
Source ClinicalTrials.gov
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