BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies

Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent/refractory Gastrointestinal Malignancies

This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 ^ 8 3 cases, Group B: 6.0X10 ^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Pancreatic Cancer
• Intervention / Treatment: Biological: Group A; Biological: Group B

Detailed Description

Main research objectives:

Evaluate the safety and tolerability of BGT007 in treating patients with recurrent/refractory multiple gastrointestinal malignancies;

Secondary research objective:

1. Evaluate the pharmacokinetic (PK) characteristics of BGT007;
2. Evaluate the preliminary effectiveness of BGT007 product.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yuqing Li, PhD; Phone Number: 15018487211; Email: liyu2t@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1: Voluntarily sign a written informed consent form;
• 2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
• 3: Expected survival period ≥ 3 months;
• 4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
• 5: Biopsy specimens or pathological paraffin sections (within 3 years prior to signing the informed consent form): target tests are both positive;
• 6: According to the RECIST v1.1 solid tumor evaluation criteria, there must be at least one measurable lesion, and the longest diameter evaluated by CT or MRI imaging in the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short diameter must be ≥ 15 mm);
• 7: Advanced pancreatic cancer or colorectal cancer confirmed by histology or cytology, which has progressed through second-line or above standard treatment, or is intolerant of standard treatment, or has no standard treatment; Definition of intolerance: According to CTCAE V5.0, during the treatment process, there is a hematological toxicity of ≥ Grade IV, non hematological toxicity of ≥ Grade III, or damage to major organs such as the heart, liver, and kidneys of ≥ Grade II; The definition of treatment failure: disease progression (PD) during the treatment process or recurrence after treatment (including postoperative recurrence);
• 8: Can establish a single or intravenous blood collection pathway, and there are no other contraindications for blood cell isolation;
• 9: Having sufficient organ and bone marrow functions
• 10: Medical contraceptive measures. Female subjects of childbearing age must undergo a pregnancy test within 72 hours before the first administration, and the result must be negative.

Exclusion Criteria:

• 1: Active central nervous system metastases (excluding those that have been treated and stabilized);
• 2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;
• 3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
• 4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
• 5: Within the 14 days prior to enrollment, there were active or uncontrollable infections that required systemic treatment;
• 6: Any unstable systemic disease (including but not limited to): active infection (excluding local infection); Unstable angina pectoris; Cerebrovascular ischemia or cerebrovascular accident (within 6 months prior to screening); Myocardial infarction (within 6 months prior to screening); Congestive heart failure (NYHA classification ≥ III); Severe arrhythmia requiring medication treatment; Heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure>160mmHg/100 mmHg);
• 7: Functional impairment of important organs such as lungs, brain, and kidneys;
• 8: The subjects have undergone major surgery or severe trauma within 4 weeks prior to receiving treatment with the investigational product, or are expected to undergo major surgery during the study period;
• 9: Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 2 weeks prior to single collection or within 5 half lives (whichever is shorter);
• 10: Received treatment with chimeric antigen receptor modified T cells (including CAR-T and TCR-T) within six months;
• 11: Severe allergies or a history of allergies;
• 12: Subjects requiring anticoagulant therapy;
• 13: Pregnant or lactating women, or those with a pregnancy plan within six months (for both men and women)
• 14: Researchers believe that there are other reasons why treatment providers cannot be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGT007; Intravenous infusion	Biological: Group A; BGT007 3.0×10^8cells,Intravenous infusion，3 subject is planned to be enrolled; Biological: Group B; BGT007 6.0×10^8cells,Intravenous infusion，6 subject is planned to be enrolled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Limiting Toxicity (DLT)	DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BGT007 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade 4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)	From the infusion (Day 0) to Day 28
Maximum Tolerated Dose(MTD)	The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BGT007 administration and completed DLT observation)	From the infusion (Day 0) to Day 28

Collaborators and Investigators

• Sponsor: BioSyngen Pte Ltd
• Collaborators: South China Hospital of Shenzhen University
• Investigators: Principal Investigator: Mingyong Han, PhD, South China Hospital of Shenzhen Univercity; Principal Investigator: Yuqing Li, PhD, South China Hospital of Shenzhen Univercity

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BR-BGT007-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No