Tumor PancreasNCT06478225
Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With Relapsed/Refractory Pancreatic Cancer
A study testing BGT007H Cell Injection in people with Tumor Pancreas, run by RenJi Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor Pancreas
- What is being tested?
- BGT007H Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntarily sign an informed consent form in writing.
- Age ≥18 years and ≤75 years, both male and female are eligible.
- Expected survival ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Can provide pathological paraffin section detection targets (within 3 years prior to signing the informed consent form).
- 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).
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- 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).
- Apheresis or venous blood collection venous access can be established, and there are no other contraindications to blood cell separation.
- 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.
- 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.
Who cannot join
- Has active central nervous system (CNS) metastasis (except for those treated and stable).
- 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.
- Has a mental or psychological disorder that cannot cooperate with treatment and efficacy evaluation.
- Subjects with severe autoimmune diseases who have been long-term users of immunosuppressants.
- Within 14 days before enrollment, there is an active infection or uncontrollable infection that requires systemic treatment.
- 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).
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- Combined with dysfunction of important organs such as lungs, brain, and kidneys.
- 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.
- 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.
- Received chimeric antigen receptor-modified T cell (CAR-T), T-cell receptor engineered T cells (TCR-T) therapy within the past 6 months.
- Severe allergies or a history of allergies.
- Subjects who require anticoagulant therapy.
- Pregnant or lactating women, or those who plan to become pregnant within six months (applicable to both men and women).
- The researcher believes that there are other reasons why the subject cannot be included in the treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji hospital
Shanghai, Shanghai Municipality, 200127
Liwei Wang, Dr, +86 16621086648, lwwang2013@163.com
About this study
Official title: Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Pancreatic Cancer
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.
Read the detailed description
This study is a single-arm, open-label, modified "3+3" dose-escalation exploratory study. The BGT007H cell therapy group will be evaluated at 5 dose levels, which are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. If a lower adverse reaction and preliminary benefit (SD or PR) are observed, the same dose will be repeated 1-2 times after a 1-month interval.
Each subject will be observed for at least 4 weeks after cell infusion (DLT observation period). The first two dose groups (3.0×10^7, 1.0×10^8 cells) will each include 1 subject, and the remaining 3 dose groups will follow the conventional "3+3" dose-escalation method. If a DLT occurs in the first subject at the first dose level, an additional 5 subjects will be included. If no DLT occurs in the expanded subjects, the study will proceed to the next higher dose group. If another subject experiences a DLT, enrollment will be halted and the study protocol will be revised. The next subject can only be enrolled if it is confirmed that the previous subject did not experience grade 3 or higher adverse events related to the study drug (CTCAE 5.0) during the DLT observation period. If no DLT occurs in a dose group, the study will proceed to the next higher dose group. In a group of 3 subjects, if one experiences a DLT, an additional 3 subjects will be included in the next higher dose group. If one out of three subjects experiences a DLT, 3 more subjects will be included in the dose group. If only one out of the expanded 6 subjects experiences a DLT, then the study will proceed to include 3 more subjects at the next higher dose. If 2 or more out of the expanded 6 subjects experience a DLT, then the dose is considered to be higher than the MTD (MTD is defined as the highest dose at which ≤1/6 or ≤2/9 subjects experience a DLT). New subjects will be enrolled at the previous lower dose (tolerated dose) group until 6 or 9 subjects are reached in the lower dose group. If ≤1/6 or ≤2/9 subjects, this lower dose group is defined as the MTD or the optimal effective dose. During the study, the investigators may consider the safety and preliminary efficacy data of the enrolled subjects, with the safety of the subjects and the maximum benefit of the disease as the premise, and conduct the study treatment at the maximum tolerated dose or other doses determined by the investigators.
- Conditions
- Tumor Pancreas
- Being tested
- BGT007H Cell Injection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGT007H Cell InjectionDrug
Intervention roughly goes through 3 phases (the day of cell infusion is defined as day 0, d0):
- Apheresis and baseline period: Eligible subjects are enrolled for leukapheresis to prepare BGT007H cell injection solution, and baseline assessment is performed from after apheresis to before preconditioning.
- Preconditioning (d-5~d-3): Patients begin preconditioning (FC regimen) 5 days before BGT007H cell administration. A 2-day rest and observation period is conducted after preconditioning. The FC regimen is as follows:
- Fludarabine: 25~30mg/m2/d, intravenous infusion, once a day, for 3 consecutive days;
- Cyclophosphamide: 250~350mg/m2/d, intravenous infusion, once a day, for 3 consecutive days.
- Cell infusion (d0) and DLT observation period (d0~d28).
| Study group | Role | What they receive |
|---|---|---|
| BGT007H Cell Injection | Experimental | A modified "3+3" dose-escalation design is used, with BGT007H cells administered at five progressively increasing dose levels for treatment evaluation. The dose levels are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. Receives: Drug: BGT007H Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Dose-Limiting Toxicity
Measured: through study completion, an average of 3 year
Maximum Tolerated Dose (MTD)
Maximum Tolerated Dose
Measured: through study completion, an average of 3 year
Optimal Biological Dose (OBD)
Optimal Biological Dose
Measured: through study completion, an average of 3 year
Adverse events (AE)
Adverse events
Measured: through study completion, an average of 3 year
Secondary outcomes (3)
Evaluate the disease control rate (DCR)
Evaluate the disease control rate ,according to the RECIST 1.1 criteria.
Measured: through study completion, an average of 3 year
Evaluate the duration of response (DOR)
Evaluate the duration of response ,according to the RECIST 1.1 criteria.
Measured: through study completion, an average of 3 year
Evaluate the progression-free survival (PFS)
Evaluate the progression-free survival, according to the RECIST 1.1 criteria.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start7 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor PancreasStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liwei Wang, Doctorate, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478225
- Sponsor's protocol ID
- BR-BGT-010
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06478225
- Acronym / sponsor ID
- BR-BGT-010
- Conditions
- Tumor Pancreas
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.
Detailed description
This study is a single-arm, open-label, modified "3+3" dose-escalation exploratory study. The BGT007H cell therapy group will be evaluated at 5 dose levels, which are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. If a lower adverse reaction and preliminary benefit (SD or PR) are observed, the same dose will be repeated 1-2 times after a 1-month interval.
Each subject will be observed for at least 4 weeks after cell infusion (DLT observation period). The first two dose groups (3.0×10^7, 1.0×10^8 cells) will each include 1 subject, and the remaining 3 dose groups will follow the conventional "3+3" dose-escalation method. If a DLT occurs in the first subject at the first dose level, an additional 5 subjects will be included. If no DLT occurs in the expanded subjects, the study will proceed to the next higher dose group. If another subject experiences a DLT, enrollment will be halted and the study protocol will be revised. The next subject can only be enrolled if it is confirmed that the previous subject did not experience grade 3 or higher adverse events related to the study drug (CTCAE 5.0) during the DLT observation period. If no DLT occurs in a dose group, the study will proceed to the next higher dose group. In a group of 3 subjects, if one experiences a DLT, an additional 3 subjects will be included in the next higher dose group. If one out of three subjects experiences a DLT, 3 more subjects will be included in the dose group. If only one out of the expanded 6 subjects experiences a DLT, then the study will proceed to include 3 more subjects at the next higher dose. If 2 or more out of the expanded 6 subjects experience a DLT, then the dose is considered to be higher than the MTD (MTD is defined as the highest dose at which ≤1/6 or ≤2/9 subjects experience a DLT). New subjects will be enrolled at the previous lower dose (tolerated dose) group until 6 or 9 subjects are reached in the lower dose group. If ≤1/6 or ≤2/9 subjects, this lower dose group is defined as the MTD or the optimal effective dose. During the study, the investigators may consider the safety and preliminary efficacy data of the enrolled subjects, with the safety of the subjects and the maximum benefit of the disease as the premise, and conduct the study treatment at the maximum tolerated dose or other doses determined by the investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGT007H Cell Injection | Experimental | Drug: BGT007H Cell InjectionA modified "3+3" dose-escalation design is used, with BGT007H cells administered at five progressively increasing dose levels for treatment evaluation. The dose levels are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- voluntarily sign an informed consent form in writing.
- Age ≥18 years and ≤75 years, both male and female are eligible.
- Expected survival ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Can provide pathological paraffin section detection targets (within 3 years prior to signing the informed consent form).
Key exclusion criteria (14 listed)
- Has active central nervous system (CNS) metastasis (except for those treated and stable).
- 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.
- Has a mental or psychological disorder that cannot cooperate with treatment and efficacy evaluation.
- Subjects with severe autoimmune diseases who have been long-term users of immunosuppressants.
- Within 14 days before enrollment, there is an active infection or uncontrollable infection that requires systemic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGT007H Cell InjectionIntervention roughly goes through 3 phases (the day of cell infusion is defined as day 0, d0): 1. Apheresis and baseline period: Eligible subjects are enrolled for leukapheresis to prepare BGT007H cell injection solution, and baseline assessment is performed from after apheresis to before preconditioning. 2. Preconditioning (d-5~d-3): Patients begin preconditioning (FC regimen) 5 days before BGT007H cell administration. A 2-day rest and observation period is conducted after preconditioning. The FC regimen is as follows: * Fludarabine: 25~30mg/m2/d, intravenous infusion, once a day, for 3 consecutive days; * Cyclophosphamide: 250~350mg/m2/d, intravenous infusion, once a day, for 3 consecutive days. 3. Cell infusion (d0) and DLT observation period (d0~d28). | Drug | BGT007H Cell Injection |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: through study completion, an average of 3 year
Dose-Limiting Toxicity
Maximum Tolerated Dose (MTD)
Time frame: through study completion, an average of 3 year
Maximum Tolerated Dose
Optimal Biological Dose (OBD)
Time frame: through study completion, an average of 3 year
Optimal Biological Dose
Adverse events (AE)
Time frame: through study completion, an average of 3 year
Adverse events
3 secondary outcomes
Evaluate the disease control rate (DCR)
Time frame: through study completion, an average of 3 year
Evaluate the duration of response (DOR)
Time frame: through study completion, an average of 3 year
Evaluate the progression-free survival (PFS)
Time frame: through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liwei Wang, Doctorate principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BGT007H Cell Injection in people with Tumor Pancreas, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuqi Wu, Doctorate (15850459057, wuxiuqi597@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: through study completion, an average of 3 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.