Clinical trial · Interventional
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| First dose | Biological | — | UNRESOLVED |
| Second dose | Biological | — | UNRESOLVED |
| The fourth dose | Biological | — | UNRESOLVED |
| The third dose | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGT007H injection
- description
- Intravenous infusion
- interventionNames
- Biological: First dose
- Biological: Second dose
- Biological: The third dose
- Biological: The fourth dose
Primary outcomes (3)
- measure
- Dose-Limiting Toxicity (DLT)
- timeFrame
- From the infusion (Day 0) to Day 28
- description
- Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).
- measure
- Maximum tolerated dose
- timeFrame
- From the infusion (Day 0) to Day 28
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available