Gastrointestinal TumorsEarly Phase 1NCT06152757
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
A Early Phase 1 study testing First dose, Second dose and The third dose in people with Gastrointestinal Tumors, run by BioSyngen Pte Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- First dose, Second dose and The third dose
- 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
- 9 Oct 2023to 19 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 5. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;
- 6. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;
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- 7. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology/cytology as having failed the standard of second-line or above treatment or are not suitable for/refuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);
- 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;
- 9, with adequate organ and bone marrow function;
- 10. 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 is negative.
Who cannot join
- 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;
- 5. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;
- 6. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association [NYHA] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100mmHg);
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- 7, combined with lung, brain, kidney and other important organ dysfunction;
- 8. 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;
- 9. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;
- 10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;
- 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;
- 12. Combined graft-versus-host disease (GVHD)
- 13. Subjects 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 hours prior to cell transfusion (except for inhalation or topical use);
- 14. Severe allergy or history of allergy;
- 15. Subjects requiring anticoagulation therapy;
- 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;
- 17. 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
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xinfeng Chen, 0371-66295320, fengxinchen1985@163.com
Dan Wang, 13383812031, dan.wang1002@163.com
About this study
Official title: Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors
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.
Read the detailed description
Main research objectives:
Evaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors
Secondary research objectives:
- Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion;
- Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors
Exploratory Purpose
- Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects;
- Exploring the correlation between target expression levels and efficacy
- Conditions
- Gastrointestinal Tumors
- Being tested
- First dose, Second dose, The third dose, The fourth dose
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First doseBiological
1.0×10^8cells,Intravenous infusion，1 subject is planned to be enrolled
Second doseBiological
3.0×10^8cells,Intravenous infusion，3 subject is planned to be enrolled
The third doseBiological
1.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled
The fourth doseBiological
3.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled
| Study group | Role | What they receive |
|---|---|---|
| BGT007H injection | Experimental | Intravenous infusion Receives: Biological: First dose; Biological: Second dose; Biological: The third dose; Biological: The fourth dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).
Measured: From the infusion (Day 0) to Day 28
Maximum tolerated dose
The maximum CAR-T dose that can be tolerated in the study.
Measured: From the infusion (Day 0) to Day 28
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).
Measured: The day of leukapheresis to 12 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start9 Oct 2023
- Primary completion19 Jul 2025 (estimated)
- Study completion19 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BioSyngen Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152757
- Sponsor's protocol ID
- BR-BGT-003
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT06152757
- Acronym / sponsor ID
- BR-BGT-003
- Conditions
- Gastrointestinal Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- BioSyngen Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 19 Jul 2025 (estimated)
- Study completion
- 19 Jul 2027 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main research objectives:
Evaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors
Secondary research objectives:
- Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion;
- Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors
Exploratory Purpose
- Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects;
- Exploring the correlation between target expression levels and efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGT007H injection | Experimental | Biological: First dose, Biological: Second dose, Biological: The third dose, Biological: The fourth doseIntravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- 5. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;
Key exclusion criteria (17 listed)
- 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;
- 5. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First dose1.0×10^8cells,Intravenous infusion，1 subject is planned to be enrolled | Biological | BGT007H injection |
| Second dose3.0×10^8cells,Intravenous infusion，3 subject is planned to be enrolled | Biological | BGT007H injection |
| The third dose1.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled | Biological | BGT007H injection |
| The fourth dose3.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled | Biological | BGT007H injection |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: From the infusion (Day 0) to Day 28
Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).
Maximum tolerated dose
Time frame: From the infusion (Day 0) to Day 28
The maximum CAR-T dose that can be tolerated in the study.
AE, SAE, AESI, CRS, ICANS, TEAE
Time frame: The day of leukapheresis to 12 months after infusion
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Zhang principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing First dose, Second dose and The third dose in people with Gastrointestinal Tumors, run by BioSyngen Pte Ltd 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 10 inclusion and 17 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 1 Dec 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?
Contact Xinfeng Chen (0371-66295320, fengxinchen1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: From the infusion (Day 0) to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.