BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies

NCT06645301 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BR-BGT007-001
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BGT007

EXPERIMENTAL

Intravenous infusion

Biological: Group A; Biological: Group B

Interventions

Group A BIOLOGICAL

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

BGT007

Group B BIOLOGICAL

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

BGT007

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• : Voluntarily sign a written informed consent form;
• : Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
• : Expected survival period ≥ 3 months;
• : The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
• : Biopsy specimens or pathological paraffin sections (within 3 years prior to signing the informed consent form): target tests are both positive;
• : 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);
• : 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);
• : Can establish a single or intravenous blood collection pathway, and there are no other contraindications for blood cell isolation;
• : Having sufficient organ and bone marrow functions
• : 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.

You may not qualify if:

• : Active central nervous system metastases (excluding those that have been treated and stabilized);
• : 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;
• : Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
• : Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
• : Within the 14 days prior to enrollment, there were active or uncontrollable infections that required systemic treatment;
• : 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);
• : Functional impairment of important organs such as lungs, brain, and kidneys;
• : 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;
• : 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);
• : Received treatment with chimeric antigen receptor modified T cells (including CAR-T and TCR-T) within six months;
• : Severe allergies or a history of allergies;
• : Subjects requiring anticoagulant therapy;
• : Pregnant or lactating women, or those with a pregnancy plan within six months (for both men and women)
• : Researchers believe that there are other reasons why treatment providers cannot be included.

Sponsors & Collaborators

• BioSyngen Pte Ltd: lead
• South China Hospital of Shenzhen University: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mingyong Han, PhD

  South China Hospital of Shenzhen Univercity

  PRINCIPAL INVESTIGATOR

• Yuqing Li, PhD

  South China Hospital of Shenzhen Univercity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqing Li, PhD

CONTACT

15018487211; liyu2t@163.com

Study Design

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

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10