BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
ConditionGastrointestinal Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioSyngen Pte Ltd
About this trial
This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.
Four dose levels were designed for this study: 1.0×10\^8cells, 3.0×10\^8cells, 1.0×10\^9cells, and 3.0×10\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.
Eligibility criteria
Qualifiers
1. Resources sign written informed consent;
2, age ≥18, male and female can;
3. Expected survival ≥3 months;
4. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;
Disqualifiers
1. Active central nervous system metastasis (except stable after treatment);
2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;
3, mental or mental illness can not cooperate with treatment and efficacy evaluation;
4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
Trial design
Treatments tested in this trial
- First dose
- Second dose
- The third dose
- The fourth dose
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
BioSyngen Pte Ltd
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Source ClinicalTrials.gov