Health TrialsbyHealthPanel

BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

ConditionGastrointestinal Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioSyngen Pte Ltd

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

1. Active central nervous system metastasis (except stable after treatment);

2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;

3, mental or mental illness can not cooperate with treatment and efficacy evaluation;

4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;

Trial design

Design model

Single group

Treatments tested in this trial

  • First dose

    Biological/Vaccine

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

  • Second dose

    Biological/Vaccine

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

  • The third dose

    Biological/Vaccine

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

  • The fourth dose

    Biological/Vaccine

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

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: BGT007H injectionExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT)

Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).

Time frame
From the infusion (Day 0) to Day 28
2

Maximum tolerated dose

The maximum CAR-T dose that can be tolerated in the study.

Time frame
From the infusion (Day 0) to Day 28
3

AE, SAE, AESI, CRS, ICANS, TEAE

The incidence of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), cytokine release syndrome (CRS) immune cell associated neurotoxicity syndrome (ICANS) and treatment-emergent adverse events (TEAE).

Time frame
The day of leukapheresis to 12 months after infusion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioSyngen Pte Ltd

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Collaborator

Source ClinicalTrials.gov
Apply now