BGT007 Cells for the Treatment of Refractory Digestive System Tumors

Sponsor
The Affiliated Hospital of Xuzhou Medical University
Study ID
NCT06104241
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BGT007 Injection — BIOLOGICAL
    BGT007 injection (d0) were infused intravenously once, and the dose group was 5.0× 10\^7 cells,1.0 ×10\^8 cells, 3.0× 10\^8 cells,1.0 × 10\^9 cells,3.0 ×10\^9 cells.

Study Details

This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007 injection in the treatment of recurrent/metastatic/refractory digestive system tumors

Key Dates

First listed
Oct 27, 2023
Start date
Oct 22, 2023
Status verified
Oct 2023
Primary completion
Oct 20, 2026
Completion
Oct 20, 2027

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BGT007 Cell Injection
    This is an exploratory study of single-arm, open, modified "3+3" dose escalation. The BGT007 cell therapy group received five progressively increased dose levels (5.0× 10\^7 cells,1.0 ×10\^8 cells, 3.0× 10\^8 cells,1.0 × 10\^9 cells,3.0 ×10\^9 cells) of BGT007 cells. Each subject was observed for at least 4 weeks after cell transfusion (DLT observation period). The first two dose groups (5.0×10\^7 cells and 1.0×10\^8 cells) included 1 subject each, and the other three dose groups were followed by conventional "3+3" dose increments.

Primary Outcome Measure

Dose-limiting toxicity (DLT） [ Time Frame: From day 0 to day 28 ]

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