BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Recruiting
Early Phase 1
Interventional Study
Gastrointestinal Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 14 (estimated)
- Sponsor
- BioSyngen Pte Ltd · Industry
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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 st…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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;
* 5\. Biopsy specimen or pathological wax section test (within 3 years before accepti…
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