Gastrointestinal Tumors Clinical Trial
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.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | July 19, 2027 |
Est. primary completion date | July 19, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 =? hematological toxicity or =? non-hematological toxicity or =? 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 =?; 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
BioSyngen Pte Ltd | The First Affiliated Hospital of Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-Limiting Toxicity (DLT) | Incidence of adverse events defined as Dose-Limiting Toxicity (DLT). | From the infusion (Day 0) to Day 28 | |
Primary | Maximum tolerated dose | The maximum CAR-T dose that can be tolerated in the study. | From the infusion (Day 0) to Day 28 | |
Primary | 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). | The day of leukapheresis to 12 months after infusion |
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