AzTrials
AzTrials

Gastrointestinal CancerEarly Phase 1NCT06104241

BGT007 Cells for the Treatment of Refractory Digestive System Tumors

A Early Phase 1 study testing BGT007 Injection in people with Gastrointestinal Cancer, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
BGT007 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteChina
Study dates
22 Oct 2023to 20 Oct 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign a written informed consent.
  • Age ≥18 years old, ≤70 years old, male and female.
  • Expected survival ≥ 3 months.
  • The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1.
  • Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent): Target protein test is positive.
  • At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria.
Show all 11Show fewer
  • Patients with recurrent/metastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance.
  • It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation.
  • having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10^9/L Platelet count (PLT) ≥80×10^9/L Hemoglobin concentration ≥90g/L Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL/min Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN
  • Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0).
  • During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose and the result are negative.

Who cannot join

  • Active central nervous system metastases (except those stable after treatment).
  • HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive.
  • Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation.
  • Subjects with severe autoimmune diseases and long-term use of immunosuppressants.
  • Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment.
  • Any unstable systemic disease (including but not limited to):
Show all 18Show fewer
  • Active infections (except local infections); unstable angina pectoris; cerebral ischemia or cerebrovascular accident (within 6 months prior to screening); myocardial infarction (within 6 months before screening); Congestive heart failure (New York Heart Association [NYHA] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100 mmHg).
  • dysfunction of important organs such as lung, brain and kidney.
  • The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy or is expected to undergo major surgery during the study period.
  • Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to an apheresis or within 5 half-lives, whichever is shorter.
  • The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years.
  • Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months.
  • Graft-versus-host disease (GVHD).
  • Participants who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 h prior to cell transfusion (except for inhalation or topical use).
  • Severe allergies or history of allergies.
  • Subjects requiring anticoagulation therapy.
  • Pregnant or breastfeeding women, or have a pregnancy plan within six months (for both men and women)
  • Researchers believe that there are other reasons for not being included in the treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • he Affiliated Hospital of Xuzhou Medical University

    Xuzhou, JangSu, 221000

    Li Li, doctor, +86-516-85609999, lily9711214@126.com

    Li Li, doctor

    Recruiting

Other trials in China

About this study

Official title: Clinical Study on the Safety and Initial Efficacy of BGT007 Cell Therapy in Patients With Recurrent/Metastatic Refractory Digestive Tract Tumors

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

Read the detailed description

The researchers designed a single arm, open, exploratory study to improve the "3+3" dose escalation. The maximum dose or the best effective dose shall be determined according to the subject and dose increasing test to verify the safe and effective number of cells per unit weight. The improved "3+3" dose increasing design was adopted, and BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 5.0 × 10^7cells，1.0 × 10^8cells，3.0 × 10^8cells，1.0 × 10^9cells，3.0 × 10^9cells. Cell reinfusion will be carried out on day 0 (d0), and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period).

Being tested
BGT007 Injection
Keywords
recurrent/metastatic/refractory
Medical subject headings
Gastrointestinal Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGT007 InjectionBiological

    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 groups in NCT06104241
Study groupRoleWhat they receive
BGT007 Cell InjectionExperimentalThis 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.
Receives: Biological: BGT007 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT）

    Adverse events related to cell therapy were observed on 28 days after BGT007 injection, as specified in protocol.

    Measured: From day 0 to day 28

Secondary outcomes (4)

  1. C max

    The amplification of BGT007 injection in peripheral blood peaked after administration.

    Measured: 12 months

  2. T max

    Number of days of peak BGT007 injection expansion after administration.

    Measured: 12 months

  3. ORR

    Reportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit. Imaging examination was performed after administration, and RECIST1.1 evaluation criteria was used for evaluation.

    Measured: 12 months

  4. PFS

    The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start22 Oct 2023
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion20 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104241
Sponsor's protocol ID
BR-BGT-007
Status last verified
Oct 2023
First submitted
23 Oct 2023
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BGT007 Injection in people with Gastrointestinal Cancer, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT） (time frame: From day 0 to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in