BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

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. 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.

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 ≥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.

Conditions2

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