Pancreatic CancerEarly Phase 1NCT06196658
Early Phase I Study of Autologous T Cells (EX02 CAR-T) for Unresectable Pancreatic/Bile Duct Cancer
A Early Phase 1 study testing anti-EX02 CAR T cells in people with Pancreatic Cancer and Advanced Biliary Cancer, run by Zhang Xiaofeng,MD.
Trial summary
This is a early Phase 1 open-label study to explore the safety and possible efficacy of EX02 CAR T cell therapy in the treatment of patients with unresectable and/or metastatic pancreatic/bile duct cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer, Advanced Biliary Cancer
- What is being tested?
- anti-EX02 CAR T cells
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Must have a confirmed diagnosis of unresectable or metastatic pancreatic cancer or bile duct cancer 2) Ineligible for, refractory to or relapsed after first or second line of chemotherapy 3) Presence of at least one measurable target lesion according to RECIST v1.1 4) EX02 positive tumor cell membrane (as shown in IHC staining of tumor specimen or in flow cytometry of ascites cells) 5) Male or female, ≥18 years 6) ECOG performance status 0 to 1 7) Expected life expectancy >3 months 8) Negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration, and willingness to practice birth control for woman with childbearing potential 9) Adequate hematology function indicated by followings (without blood transfusion or administration with growth factors in last four weeks):
- Neutrophil count ≥ 1.5×10^9/L
- Hemoglobin ≥ 90g/L
- Platelet count ≥ 100×10^9/L
- Lymphocyte count ≥ 0.5×10^9/L 10) Adequate liver, kidney, heart and lung functions at least indicated by:
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- Creatinine clearance ≥ 60ml/min
- ALT and AST ≤ 2.5 ULN (≤ 5 ULN when liver is involved)
- LVEF ≥ 50%; absence of pericardial fluid; no significant abnormality in ECG exam
- No or only small amount of pleural fluid or ascites; blood oxygen saturation ≥ 95% 11) Voluntary participation in the trial and signing informed consent form
- Must have a confirmed diagnosis of unresectable or metastatic pancreatic cancer or bile duct cancer
- Ineligible for, refractory to or relapsed after first or second line of chemotherapy
- Presence of at least one measurable target lesion according to RECIST v1.1
- EX02 positive tumor cell membrane (as shown in IHC staining of tumor specimen or in flow cytometry of ascites cells)
- Male or female, ≥18 years
- ECOG performance status 0 to 1
- Expected life expectancy >3 months
- Negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration, and willingness to practice birth control for woman with childbearing potential
- Adequate hematology function indicated by followings (without blood transfusion or administration with growth factors in last four weeks):
- Neutrophil count ≥ 1.5×10^9/L
- Hemoglobin ≥ 90g/L
- Platelet count ≥ 100×10^9/L
- Lymphocyte count ≥ 0.5×10^9/L
- Adequate liver, kidney, heart and lung functions at least indicated by:
- Creatinine clearance ≥ 60ml/min
- ALT and AST ≤ 2.5 ULN (≤ 5 ULN when liver is involved)
- LVEF ≥ 50%; absence of pericardial fluid; no significant abnormality in ECG exam
- No or only small amount of pleural fluid or ascites; blood oxygen saturation ≥ 95%
- Voluntary participation in the trial and signing informed consent form
Who cannot join
- 28 participants fulfilling the following criteria will be enrolled.
- Active viral infection including but not limiting hepatitis A, hepatitis B, hepatitis C or HIV
- History of acquired immunodeficiency syndrome (AIDS)
- Is pregnant or lactating
- Unwilling to practice birth control
- Planned intraperitoneal chemotherapy (such as HIPEC) within 28 days
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- Received systemic immune inhibitors or corticosteroids (prednisone 15mg/day or above equivalent dose) within 2 weeks of the time of initiating conditioning chemotherapy
- Current involvement of:
- Active infection which requires treatment with systemic administration
- Active coagulation disorders or receiving anti-coagulant treatment (except for aspirin)
- Active hemolytic anemia
- Significant arrhythmia, or history of myocardial infarction, ventricular tachycardia, or ventricular fibrillation
- Active obstructive or constrictive lung disease
- Active autoimmune disease such as rheumatoid arthritis or immunodeficiency disease
- Active CNS metastases or cerebrospinal malignancy
- Uncontrolled diseases including disorders of cardiovascular, respiratory, renal, gastrointestinal, urogenital or immune systems
- Active second malignancy in addition to the studied one, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
- History of hypersensitivity to any drugs planning to be used in this study
- History of treatment with any genetically modified T cell therapy (including CAR T cells and TCR T cells)
- Any conditions that investigator consider as ineligibility of participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaofeng Zhang contact
About this study
Official title: Early Phase I Study of Autologous T Cells Engineered to Express Anti-EX02 Chimeric Antigen Receptor (EX02 CAR-T) for Unresectable Pancreatic/Bile Duct Cancer
This is a early Phase 1 open-label study to explore the safety and possible efficacy of EX02 CAR T cell therapy in the treatment of patients with unresectable and/or metastatic pancreatic/bile duct cancer.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an intra-tumoral injection or intraperitoneal infusion of Ex02 CAR T cells, probably followed by an intravenous infusion of EX02 CAR T cells.
Each participant will proceed through the following study procedures:
- Screening
- Enrollment/Leukapheresis
- Conditioning chemotherapy
- CAR T treatment
- Post-treatment assessment
- Long-term follow-up
- Conditions
- Pancreatic Cancer, Advanced Biliary Cancer
- Being tested
- anti-EX02 CAR T cells
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-EX02 CAR T cellsDrug
Conditioning chemotherapy:
- Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before first administration of first time of intravenous or intraperitoneal infusion
Investigational Product:
- Regional administration: Acetaminophen 500mg orally and diphenhydramine 20mg intramuscularly (or other non-steroidal anti-inflammatory drugs and antihistamines) were given in advance on the day of administration (day 0). Intraperitoneal infusion or intra-tumoral injection of anti-EX02 CAR T cells, with dosage and method determined by the investigator
- Intravenous administration: Single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 2 x 106 anti-EX02 CAR T cells/kg, 30 minutes after premedication with oral acetaminophen 500mg and intramuscular diphenhydramine 20mg
| Study group | Role | What they receive |
|---|---|---|
| anti-EX02 CAR T cells | Experimental | Not described Receives: Drug: anti-EX02 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-related adverse events (TEAEs)
Grade and type of toxicity per dose level; fraction of patients who experience toxicity (including allergic reactions to T cell infusions) of ≥ Grade 3 according to CTCAEv5.0, cytokine release syndrome (CRS) of ≥ Grade 3 according to ASTCT consensus and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
Measured: 4 weeks after the first CAR-T cell infusion
Objective Response Rate
Objective Response Rate (ORR) is the proportion of participants with an objective response (either a complete response [CR] or partial response [PR]) in participants who received at least 1 dose of EX02CART and at least the 6-week tumor evaluation as determined by the investigator according to RECIST v1.1.
Measured: 24 weeks
Secondary outcomes (5)
Progression Free Survival (PFS)
PFS is the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: 24 weeks
Duration of Response (DOR)
DOR is the time from onset of response to progression or death due to any reason, whichever occurs first.
Measured: 24 weeks
Overall survival (OS)
OS is the time between the date of first dose and the date of death due to any reason.
Measured: 24 weeks
Disease control rate (DOC)
DOC is the proportion of participants with a stable disease (SD) or an objective response (CR or PR) in participants who received at least 1 dose of EX02CART and at least the 6-week tumor evaluation as determined by the investigator according to RECIST v1.1.
Measured: 24 weeks
5) Volume of ascites measured by ultrasonography and/or frequency and volume of ascites aspiration
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Xiaofeng,MD
- Sponsor type
- University, hospital or other
- Collaborators
- Zeno Therapeutics Pte. Ltd
- Responsible party
- Sponsor-investigator, Zhang Xiaofeng,MD, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196658
- Sponsor's protocol ID
- 20231226
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase I Study of Autologous T Cells Engineered to Express Anti-EX02 Chimeric Antigen Receptor (EX02 CAR-T) for Unresectable Pancreatic/Bile Duct Cancer
- ClinicalTrials.gov ID
- NCT06196658
- Acronym / sponsor ID
- 20231226
- Conditions
- Pancreatic Cancer, Advanced Biliary Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Zhang Xiaofeng,MDUniversity, hospital or other
- Collaborators
- Zeno Therapeutics Pte. Ltd
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 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.
This is a early Phase 1 open-label study to explore the safety and possible efficacy of EX02 CAR T cell therapy in the treatment of patients with unresectable and/or metastatic pancreatic/bile duct cancer.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an intra-tumoral injection or intraperitoneal infusion of Ex02 CAR T cells, probably followed by an intravenous infusion of EX02 CAR T cells.
Each participant will proceed through the following study procedures:
- Screening
- Enrollment/Leukapheresis
- Conditioning chemotherapy
- CAR T treatment
- Post-treatment assessment
- Long-term follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-EX02 CAR T cells | Experimental | Drug: anti-EX02 CAR T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 1) Must have a confirmed diagnosis of unresectable or metastatic pancreatic cancer or bile duct cancer 2) Ineligible for, refractory to or relapsed after first or second line of chemotherapy 3) Presence of at least one measurable target lesion according to RECIST v1.1 4) EX02 positive tumor cell membrane (as shown in IHC staining of tumor specimen or in flow cytometry of ascites cells) 5) Male or female, ≥18 years 6) ECOG performance status 0 to 1 7) Expected life expectancy >3 months 8) Negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration, and willingness to practice birth control for woman with childbearing potential 9) Adequate hematology function indicated by followings (without blood transfusion or administration with growth factors in last four weeks):
- <!-- -->
- Must have a confirmed diagnosis of unresectable or metastatic pancreatic cancer or bile duct cancer
- Ineligible for, refractory to or relapsed after first or second line of chemotherapy
- Presence of at least one measurable target lesion according to RECIST v1.1
Key exclusion criteria (20 listed)
- 28 participants fulfilling the following criteria will be enrolled.
- Active viral infection including but not limiting hepatitis A, hepatitis B, hepatitis C or HIV
- History of acquired immunodeficiency syndrome (AIDS)
- Is pregnant or lactating
- Unwilling to practice birth control
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 |
|---|---|---|
| anti-EX02 CAR T cellsConditioning chemotherapy: • Lymphodepletion regimen consisting of fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day for 3 consecutive days, administered 48 hours before first administration of first time of intravenous or intraperitoneal infusion Investigational Product: • Regional administration: Acetaminophen 500mg orally and diphenhydramine 20mg intramuscularly (or other non-steroidal anti-inflammatory drugs and antihistamines) were given in advance on the day of administration (day 0). Intraperitoneal infusion or intra-tumoral injection of anti-EX02 CAR T cells, with dosage and method determined by the investigator • Intravenous administration: Single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 2 x 106 anti-EX02 CAR T cells/kg, 30 minutes after premedication with oral acetaminophen 500mg and intramuscular diphenhydramine 20mg | Drug | anti-EX02 CAR T cells |
Primary outcome
Frequency and severity of treatment-related adverse events (TEAEs)
Time frame: 4 weeks after the first CAR-T cell infusion
Grade and type of toxicity per dose level; fraction of patients who experience toxicity (including allergic reactions to T cell infusions) of ≥ Grade 3 according to CTCAEv5.0, cytokine release syndrome (CRS) of ≥ Grade 3 according to ASTCT consensus and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
Objective Response Rate
Time frame: 24 weeks
Objective Response Rate (ORR) is the proportion of participants with an objective response (either a complete response [CR] or partial response [PR]) in participants who received at least 1 dose of EX02CART and at least the 6-week tumor evaluation as determined by the investigator according to RECIST v1.1.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: 24 weeks
Duration of Response (DOR)
Time frame: 24 weeks
Overall survival (OS)
Time frame: 24 weeks
Disease control rate (DOC)
Time frame: 24 weeks
5) Volume of ascites measured by ultrasonography and/or frequency and volume of ascites aspiration
Time frame: 24 weeks
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 9 Jan 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.
Xiaofeng Zhang contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-EX02 CAR T cells in people with Pancreatic Cancer and Advanced Biliary Cancer, run by Zhang Xiaofeng,MD.
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 29 inclusion and 20 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: opening soon, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaofeng Zhang (057156005600, zxf837@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of treatment-related adverse events (TEAEs) (time frame: 4 weeks after the first CAR-T cell infusion). The study lists 2 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 9 Jan 2024.