BGT007H Cells for the Treatment of Refractory Digestive System Tumors

NCT06104215 | Recruiting Early Phase 1

• 1 other identifier: BR-BGT-005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory clinical study evaluating the safety and initial efficacy of BGT007H injection in the treatment of recurrent/metastatic/refractory digestive system tumors.

Conditions

Digestive Tract Cancer

Keywords

recurrent/metastatic/refractory

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity（DLT）

  Adverse events related to cell therapy were observed on 28 days after BGT007H injection , as specified in the protocol

  From day 0 to day 28

Secondary Outcomes (4)

• Cmax

  12 months

• Tmax

  12 months

• ORR

  12 months

• PFS

  12 months

Study Arms (1)

BGT007H Cell Injection

EXPERIMENTAL

This is an exploratory study of single-arm, open, modified "3+3" dose escalation. The BGT007H cell therapy group received five progressively increased dose levels (2.0× 10\^8,5.0 ×10\^8, 1.0× 10\^9,3.0 × 10\^9,6.0 ×10\^9) of BGT007H cells. Each subject was observed for at least 4 weeks after cell transfusion (DLT observation period). The first two dose groups (2.0×10\^8 cells and 5.0×10\^8 cells) included 1 subject each, and the other three dose groups were followed by conventional "3+3" dose increments.

Biological: BGT007H Injection

Interventions

BGT007H Injection BIOLOGICAL

BGT007H injection (d0) were infused intravenously once, and the dose group was 2.0× 10\^8 cells,5.0 ×10\^8 cells, 1.0× 10\^9 cells,3.0 × 10\^9 cells,6.0 ×10\^9 cells.

BGT007H Cell Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a written informed consent;
• Age ≥18 years old, ≤70 years old, male and female;
• Expected survival ≥ 3 months;
• The Eastern Cancer Collaboration (ECOG) physical fitness score was 0-1;
• Biopsy specimen or pathological wax section test (within 3 years before the signing of informed consent) : Target protein test is positive;
• At least one measurable lesion according to RECIST v1.1 solid tumor evaluation criteria;
• Patients with recurrent/metastatic refractory digestive tract tumors (esophageal, gastric, pancreatic, or colorectal cancer) who have previously received second-line or above standard treatment failure or intolerance;
• It is possible to establish a vein access for simple or intravenous blood collection, and there are no other contraindications for blood cell separation;
• having adequate organ and bone marrow function, as defined below: Blood routine examination Neutrophil count (NEU #) ≥1.0×10\^9/L Platelet count (PLT) ≥80×10\^9/L Hemoglobin concentration ≥90g/L Liver function: subjects without liver metastases Aspartate aminotransferase (AST) ≤2.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) ≤2.5× Upper Limit of Normal (ULN) Total bilirubin (TBIL) ≤1.5×ULN Liver function: Subjects with liver metastases Aspartate aminotransferase (AST) ≤5× Upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤5× Upper limit of normal (ULN) Liver function: Subjects with liver metastases or Gilbert syndrome Total bilirubin (TBIL) ≤2×ULN renal function Creatinine clearance (CCR) ≥50 mL/min Coagulation function International Standardized ratio (INR) ≤1.5×ULN Activated partial thromboplastin time (APTT) ≤1.5×ULN
• Toxic side effects left over from previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);
• 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.

You may not qualify if:

• Active central nervous system metastases (except those stable after treatment);
• HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;
• Patients with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
• Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
• Active or uncontrolled infections requiring systemic treatment during the 14 days prior to enrollment;
• 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 before screening); Congestive heart failure (New York Heart Association \[NYHA\] classification ≥III); Severe arrhythmias requiring medical treatment; have a heart condition that requires treatment or uncontrolled hypertension after treatment (blood pressure \> 160mmHg/100 mmHg);
• dysfunction of important organs such as lung, brain and kidney;
• 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;
• Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 1-2 weeks prior to anapheresis or within 5 half-lives, whichever is shorter;
• The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignant tumors with disease-free survival of more than 5 years;
• Received chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months;
• Graft-versus-host disease (GVHD);
• Participants 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 h prior to cell transfusion (except for inhalation or topical use);
• Severe allergies or history of allergies;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• Guangzhou Bioresette Biomedical Technology Co., Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: October 22, 2023
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2027
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

CN (1)