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BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

NCT06152757 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-12-01

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Tumors

Interventions

BIOLOGICAL

First dose

1.0×10\^8cells,Intravenous infusion，1 subject is planned to be enrolled

BIOLOGICAL

Second dose

3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled

BIOLOGICAL

The third dose

1.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled

BIOLOGICAL

The fourth dose

3.0×10\^9cells,Intravenous infusion，3 subject is planned to be enrolled

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • BioSyngen Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Yi Zhang · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2025-07-19
Completion
2027-07-19

Countries

  • China

Study Locations

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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 NCT06152757 on ClinicalTrials.gov