BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies

NCT ID: NCT06645301

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2027-08-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BGT007

Intravenous infusion

Group Type: EXPERIMENTAL

Group A

Intervention Type: BIOLOGICAL

BGT007 3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled

Group B

Intervention Type: BIOLOGICAL

BGT007 6.0×10\^8cells,Intravenous infusion，6 subject is planned to be enrolled

Interventions

Group A

BGT007 3.0×10\^8cells,Intravenous infusion，3 subject is planned to be enrolled

Intervention Type: BIOLOGICAL

Group B

BGT007 6.0×10\^8cells,Intravenous infusion，6 subject is planned to be enrolled

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South China Hospital of Shenzhen University

UNKNOWN

Sponsor Role: collaborator

BioSyngen Pte Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingyong Han, PhD

Role: PRINCIPAL_INVESTIGATOR

South China Hospital of Shenzhen Univercity

Yuqing Li, PhD

Role: PRINCIPAL_INVESTIGATOR

South China Hospital of Shenzhen Univercity

Central Contacts

Yuqing Li, PhD

Role: CONTACT

liyu2t@163.com

15018487211

Other Identifiers

BR-BGT007-001

Identifier Type: -

Identifier Source: org_study_id