Evaluating BGT007H cell therapy for pancreatic cancer

Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Pancreatic Cancer

This study is testing a new cell therapy called BGT007H to see if it can safely help people with pancreatic cancer that has come back or didn't respond to other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (other)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06478225 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of BGT007H cell therapy in patients with relapsed or refractory pancreatic cancer. It employs a single-arm, open-label design with a modified '3+3' dose-escalation approach, testing five different dose levels of BGT007H cells. Participants will be monitored for adverse reactions and preliminary benefits over a minimum observation period of four weeks following cell infusion. The study will adjust enrollment based on the occurrence of dose-limiting toxicities (DLTs) to ensure patient safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced pancreatic cancer that has progressed after standard treatments.

Not a fit: Patients with early-stage pancreatic cancer or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced pancreatic cancer who have limited alternatives.

How similar studies have performed: While there have been various approaches to cell therapies in cancer treatment, the specific application of BGT007H for pancreatic cancer is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. voluntarily sign an informed consent form in writing.
2. Age ≥18 years and ≤75 years, both male and female are eligible.
3. Expected survival ≥ 3 months.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
5. Can provide pathological paraffin section detection targets (within 3 years prior to signing the informed consent form).
6. According to the RECIST v1.1 criteria for the evaluation of solid tumors, there must be at least one measurable lesion, and the longest diameter of the lesions assessed by CT or MRI at baseline must be ≥ 10 mm (excluding lymph nodes, for which the short diameter must be ≥ 15 mm).
7. Advanced pancreatic cancer confirmed by histology or cytology, with progression after second-line or later standard treatment, or intolerance to standard treatment, or no standard treatment available. The definition of intolerance: according to CTCAE v5.0, grade ≥IV hematological toxicity or grade ≥III non-hematological toxicity or grade ≥II damage to major organs such as heart, liver, and kidney occurred during treatment. The definition of treatment failure: disease progression (PD) during treatment or recurrence after treatment (including postoperative recurrence).
8. Apheresis or venous blood collection venous access can be established, and there are no other contraindications to blood cell separation.
9. Has adequate organ and bone marrow function, defined as follows: Blood routine: Neutrophil count (NEUT#) ≥1.0×10\^9/L Platelet count (PLT) ≥70×10\^9/L Hemoglobin concentration ≥80g/L Liver function: For subjects without liver metastasis: Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤2.5× ULN Total bilirubin (TBIL) ≤1.5× ULN For subjects with liver metastasis: AST ≤5× ULN ALT ≤5× ULN For subjects with liver metastasis or Gilbert's syndrome: Total bilirubin (TBIL) ≤2.5× ULN Renal function: Creatinine clearance rate (CCR) ≥50 mL/min Coagulation function: International normalized ratio (INR) ≤1.5× ULN Activated partial thromboplastin time (APTT) ≤1.5× ULN Coagulation function in subjects with liver metastasis: INR ≤2× ULN APTT ≤2× ULN.
10. During the study period and within 6 months after the end of dosing, subjects with childbearing potential (both male and female) must use effective medical contraception measures. Female subjects of childbearing potential must undergo a pregnancy test within 72 hours before the first dosing, and the result must be negative.

Exclusion Criteria:

1. Has active central nervous system (CNS) metastasis (except for those treated and stable).
2. HIV positive, HBsAg positive with positive Hepatitis B virus (HBV) DNA copy number (greater than the lower limit of detection), Hepatitis C virus (HCV) antibody positive and HCV RNA positive, syphilis non-treponemal antibody (RPR or TRUST) positive.
3. Has a mental or psychological disorder that cannot cooperate with treatment and efficacy evaluation.
4. Subjects with severe autoimmune diseases who have been long-term users of immunosuppressants.
5. Within 14 days before enrollment, there is an active infection or uncontrollable infection that requires systemic treatment.
6. Any unstable systemic diseases (including but not limited to): active infection (except for localized infection); unstable angina; cerebral ischemia or cerebral stroke (within 6 months of screening); myocardial infarction (within 6 months of screening); congestive heart failure (New York Heart Association (NYHA) class ≥ III); severe arrhythmia requiring medication treatment; heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure \> 160 mmHg/100 mmHg).
7. Combined with dysfunction of important organs such as lungs, brain, and kidneys.
8. Within 4 weeks before receiving cell therapy, the subject has undergone major surgery or serious trauma, or is expected to undergo major surgery during the study period.
9. Within 1-2 weeks or 5 half-lives (whichever is shorter) before apheresis, the subject has received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy.
10. Received chimeric antigen receptor-modified T cell (CAR-T), T-cell receptor engineered T cells (TCR-T) therapy within the past 6 months.
11. Severe allergies or a history of allergies.
12. Subjects who require anticoagulant therapy.
13. Pregnant or lactating women, or those who plan to become pregnant within six months (applicable to both men and women).
14. The researcher believes that there are other reasons why the subject cannot be included in the treatment.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Liwei Wang, Doctorate — RenJi Hospital
• Study coordinator: Xiuqi Wu, Doctorate

Conditions: Tumor Pancreas