Trials / Not Yet Recruiting
Not Yet RecruitingNCT06645301
BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies
Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent/refractory Gastrointestinal Malignancies
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- BioSyngen Pte Ltd · Industry
- Sex
- All
- Age
- 17 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Main research objectives: Evaluate the safety and tolerability of BGT007 in treating patients with recurrent/refractory multiple gastrointestinal malignancies; Secondary research objective: 1. Evaluate the pharmacokinetic (PK) characteristics of BGT007; 2. Evaluate the preliminary effectiveness of BGT007 product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Group A | BGT007 3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled |
| BIOLOGICAL | Group B | BGT007 6.0×10\^8cells,Intravenous infusion，6 subject is planned to be enrolled |
Timeline
- Start date
- 2024-11-30
- Primary completion
- 2026-08-31
- Completion
- 2027-08-31
- First posted
- 2024-10-16
- Last updated
- 2024-10-16
Source: ClinicalTrials.gov record NCT06645301. Inclusion in this directory is not an endorsement.