Pancreatic Cancer Non-resectableEarly Phase 1NCT06478459
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer
A Early Phase 1 study testing CAR-NK in people with Pancreatic Cancer Non-resectable, run by Zhejiang University at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2024to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 18~75 years old (including boundary value), both male and female.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
- Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient\'s refusal of surgery are also eligible for enrollment.
- ECOG PS score of 0-1.
- At least 3 months of life expectancy at screening, as judged by the investigator.
- Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, and there should be no ongoing supportive care (\"jaundice relieve\" therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct). a) Blood biochemistry: serum creatinine ≤ 1.5×ULN, serum total bilirubin ≤ 2.0×ULN, and serum liver aminotransferase ≤ 3 ×ULN b) Blood tests: neutrophil count ≥ 1.5×109/L, platelet count ≥ 60×109/L, hemoglobin ≥ 8.0g/dL, lymphocyte count ≥ 0.4×109/L;
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- Childbearing status: not pregnant and, if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form until 6 months after the last cell infusion (women of childbearing potential include premenopausal women and women within 2 years of postmenopausal time).
- Subjects must sign a written informed consent form.
- Subjects must be voluntary and able to comply with the scheduled treatment regimen, laboratory tests, follow-up, and other study requirements.
Who cannot join
- Pregnant and lactating females.
- Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
- In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to treatment.
- History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Any other health condition by the judgment of the investigator would preclude participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhejiang University，school of medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study to Evaluate the Safety and Anti-tumor Efficacy of Intratumoral NKG2D CAR-NK Cell Injection Guided by EUS in the Treatment of Locally Advanced Pancreatic Cancer.
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- CAR-NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-NKBiological
Endoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with intravenous CAR-NK infusion twice at day 4 and 5
| Study group | Role | What they receive |
|---|---|---|
| CAR-NK：intratumoral injection combined with intravenous infusion | Experimental | Not described Receives: Biological: CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose
Measured: within 28 days after NKG2D CAR-NK treatment
Dose limiting toxicity
Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK
Measured: From enrollment of the first subject to completion of follow-up of the last subject（up to 2 years））
Secondary outcomes (2)
Effectiveness evaluation
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
Measured: At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment
Cell continued survival time in vivo
Detect the copy number of NKG2D CAR DNA in peripheral blood at each visit point after the end of the infusion, until any 2 consecutive test results were negative
Measured: At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment
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 start9 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478459
- Sponsor's protocol ID
- IIT-C1/22A1-08
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 27 Dec 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study to Evaluate the Safety and Anti-tumor Efficacy of Intratumoral NKG2D CAR-NK Cell Injection Guided by EUS in the Treatment of Locally Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT06478459
- Acronym / sponsor ID
- IIT-C1/22A1-08
- Conditions
- Pancreatic Cancer Non-resectable
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (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.
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-NK：intratumoral injection combined with intravenous infusion | Experimental | Biological: CAR-NK |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18~75 years old (including boundary value), both male and female.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
- Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient\'s refusal of surgery are also eligible for enrollment.
- ECOG PS score of 0-1.
- At least 3 months of life expectancy at screening, as judged by the investigator.
Key exclusion criteria (5 listed)
- Pregnant and lactating females.
- Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
- In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to treatment.
- History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Any other health condition by the judgment of the investigator would preclude participation in the study.
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 |
|---|---|---|
| CAR-NKEndoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with intravenous CAR-NK infusion twice at day 4 and 5 | Biological | CAR-NK：intratumoral injection combined with intravenous infusion |
Primary outcome
Maximum tolerated dose
Time frame: within 28 days after NKG2D CAR-NK treatment
Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose
Dose limiting toxicity
Time frame: From enrollment of the first subject to completion of follow-up of the last subject（up to 2 years））
Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK
2 secondary outcomes
Effectiveness evaluation
Time frame: At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment
Cell continued survival time in vivo
Time frame: At weeks 4，8 and months 3，6，9，12，16，20 and 24 after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-NK in people with Pancreatic Cancer Non-resectable, run by Zhejiang University 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Dec 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Zhang, M.D. (8613858108798, qi.zhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: within 28 days after NKG2D CAR-NK treatment). 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 27 Dec 2024.