MedTrace Logo

BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies

NCT06645301 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-10-16

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • South China Hospital of Shenzhen University

    collaborator UNKNOWN

  • BioSyngen Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Mingyong Han, PhD · South China Hospital of Shenzhen Univercity

  • Yuqing Li, PhD · South China Hospital of Shenzhen Univercity

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-08-31
Completion
2027-08-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06645301 on ClinicalTrials.gov