Status:
RECRUITING
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Lead Sponsor:
BioSyngen Pte Ltd
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Gastrointestinal Tumors
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 en...
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: 1. Evaluate ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 19 2027
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06152757
Start Date
October 9 2023
End Date
July 19 2027
Last Update
December 1 2023
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China