BGT007H cell therapy for treating recurrent gastrointestinal tumors
Official title: Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors
Run by BioSyngen Pte Ltd · NCT06152757 · Data updated 2026-11-12
This study is testing a new cell therapy called BGT007H to see if it is safe and effective for people with recurrent gastrointestinal tumors.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 14 (estimated) |
| Sponsor | BioSyngen Pte Ltd Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | October 9, 2023 |
| Main results expected | July 19, 2025 |
| Study ends | July 19, 2027 |
| Registry record updated | December 1, 2023 |
| Trial ID | NCT06152757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with advanced gastrointestinal tumors who have failed standard treatments or are not suitable for them.
✕Probably not a fit
Patients with gastrointestinal tumors who have not yet undergone second-line treatment or have not been diagnosed with recurrent or refractory disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This exploratory study evaluates the safety and tolerability of BGT007H cell therapy in patients with recurrent or refractory gastrointestinal tumors. It is a single-arm, open-label, modified '3+3' dose escalation study involving approximately 11 to 14 subjects. Participants will receive varying doses of BGT007H cells to determine the maximum tolerated dose and assess initial effectiveness. The study also aims to explore the pharmacokinetic profile of the therapy and its correlation with therapeutic effects.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat gastrointestinal tumors.
How similar studies have gone: While this approach is exploratory, similar cell therapies have shown promise in treating various cancers, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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); * 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.
Where it's running
-
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Recruiting
Study contacts
- Principal investigator: Yi Zhang — The First Affiliated Hospital of Zhengzhou University
- Study coordinator: Xinfeng Chen
- Email: fengxinchen1985@163.com
- Phone: 0371-66295320
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
BL-M08D in patients with digestive tract and other solid tumors
A early-stage study to see if BL-M08D1 can be safely given and help people with advanced digestive tract cancers and other solid tumors.
-
BL-ARC002 in patients with advanced solid tumors
This study tests BL-ARC002 to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors.
-
Gastrointestinal cancer screening using a multi-target detection model
A randomized trial tests whether a combined blood and stool screening approach can reduce 5-year gastrointestinal cancer deaths compared with standard routine observation.
-
SKB571 in Gastrointestinal Tumors
A Phase 2, open-label study tests SKB571 in adults with gastrointestinal tumors to see if it is safe and may help shrink tumors.
-
KQB198 plus imatinib for first-line advanced or metastatic GIST
This Phase 2 test will see if adding the experimental drug KQB198 to imatinib helps people with advanced or metastatic GIST who are starting first-line treatment.
-
BL-M24D1 treatment for advanced gastrointestinal and other solid tumors
This trial will test BL-M24D1 in adults with locally advanced or metastatic gastrointestinal and other solid tumors to see if it is safe, tolerated, and shows early signs of anti-tumor activity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.