Advanced Pancreatic CancerEarly Phase 1NCT05438797
The Safety and Efficacy of Specific TIL-TCM Cells for Advanced Relapse-refractory or Metastatic Pancreatic Cancer
A Early Phase 1 study testing Adoptive TIL-TCM transfer therapy in people with Advanced Pancreatic Cancer, run by Sizhen Wang at 1 site in China.
Trial summary
Clinical Study on the Safety and Efficacy of specific TIL-TCM cells for advanced relapse-refractory or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Adoptive TIL-TCM transfer therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2021to Apr 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged≥18 years old and ≤70 years old when signing the informed consent; regardless of gender;Body weight>40kg.
- Patients with advanced recurrent refractory or metastatic pancreatic cancer who have failed at least one standard treatment or who are unable to tolerate, unwilling or financially unable to receive standard treatment.
- The subject will have at least one eligible tissue or sample available for cell preparation.
- Patients with brain metastatic lesions who are asymptomatic , the diameter of a single lesion ≤1 cm, and the number of lesions ≤3 may be eligible.
- Patients should have good clinical presentation status (ECOG 0 or 1).
- HIV antibody and treponema pallidum antibody was negative.
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- Vital organ function test (do not accept any cytokines or blood transfusion within 14 days prior to test):
- 1)absolute neutrophil count (ANC) ≥1000/μL; 2)White blood cell count (WBC) 3000/μL; 3)Platelet count (PLT) 75,000 /μL; 4)Hemoglobin (Hb) > 8.0 g/dL; 5) Coagulation: activated partial thromboplastin time (APTT) ≤1.5×ULN, international normalized ratio (INR) or Prothrombin time (PT)≤1.5×ULN; 6) Liver functions: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤5.0 ×ULN; 7) Liver functions:Total bilirubin (TBIL)<1.5×ULN (baseline value normal); <1.0 - 1.5×ULN( baseline value abnormal); If diagnosed as Gilbert syndrome, ≤3.0 mg/dL; The test results should prevail of the center laboratory ; 8)Renal function: eGFR>60 mL/min or 6-24 hours CrCl>60 mL/min; 9)Heart Doppler ultrasound:LVEF≥50%;
- 8.Non-surgically sterilized women of child-bearing age are required to consent to use at least one medically approved contraceptive method during the study and one year after completion.Women of child-bearing age must be negative for pregnancy test at 7 days before initiation of the treatment.Male subjects must agree to use medically approved contraception from the time they sign the informed consent form to the time they leave the study.
- 9.Expected survival no less than 3 months.
Who cannot join
- Pregnancy or lactation;
- Active infections requiring systemic anti-infective therapy ( topical antibiotics excepted);
- Patients who are taking systemic steroids or immunosuppressive drugs;
- Hepatitis B (hepatitis B surface antigen [HbsAg] and/or core antibody [HbcAb] positive, HBV-DNA<1000 copies /mL can be included);
- Hepatitis C ( HCV antibody positive and HCV-RNA positive);
- Serious autoimmune diseases or immunodeficiency disease, such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (eg., Wegener's granulomatosis);
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- Allergic:Severe allergies to the drugs used in the study; Contraindications for IL-2 used ;
- Patients with other active malignancies within the past 5 years, but not those who were clinically cured within 5 years of diagnosis of cervical epithelial carcinoma, basal or squamous skin cancer, superficial bladder cancer, breast cancer in situ and did not require follow-up;
- Any mental diseases, including dementia and changes in mental status that may influence the understanding about the informed consent and questionnaire;
- Unstable disease of heart head blood-vessel, including but not limited to, the heart cerebrovascular accident or transient ischemic (within 6 months prior to screening) myocardial infarction (within 6 months prior to screening)/vein thrombosis (within 6 months prior to screening, require surgery to repair the aortic aneurysm or proximal artery thrombosis group shall not enter into) unstable angina New York Heart Association (NYHA) Classification≥ III congestive heart failure severe arrhythmias poorly controlled by medications and severe hypertension that cannot be controlled by treatment or is untreated (systolic pressure≥160 mmHg and/or diastolic pressure≥100 mmHg );
- Patients with severe interstitial pneumonia other active pneumonia or bronchospasm and other respiratory diseases that seriously affect lung function;
- Patients with active gastrointestinal bleeding;
- Had major surgery within 1 month prior to screening or during the study ;
- Enrolled in other clinical trials (including other adoptive cell immunotherapies) and used the investigational drug within 1 month prior to screening.
- Have received live attenuated vaccine within 1 month prior to screening or are expected to receive live attenuated vaccine during the study ;
- Received any systemic antitumor drug therapy (including chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy or other biotherapy) within 4 weeks prior to pretreatment;
- Have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- Alcohol, drug or substance abuse;
- Judged as serious uncontrollable diseases by the researchers, or other conditions that may interfere with the treatment and therefore being ineligible.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu
Xinbo Wang, MD, 13505172912, wxinbo2008@163.com
Sizhen Wang, MD, 15195900565, wsizhen@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of Specific TIL-TCM Cells for Advanced Relapse-refractory or Metastatic Pancreatic Cancer
Clinical Study on the Safety and Efficacy of specific TIL-TCM cells for advanced relapse-refractory or metastatic pancreatic cancer.
Read the detailed description
This is a single arm, open-label, single-center study.This study is indicated for advanced relapse-refractory or metastatic pancreatic cancer.The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. Primary objective is to explore the safety, main consideration is dose-related safety.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Adoptive TIL-TCM transfer therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoptive TIL-TCM transfer therapyDrug
Also called TIL-TCM
Abraxane:100-200 mg/m2，QD×1D;Cyclophosphamide:15-35 mg/kg/d，QD×2D. Biological: Adoptive TIL-TCM transfer therapy
| Study group | Role | What they receive |
|---|---|---|
| adoptive TIL-TCM transfer | Experimental | TIL-TCM cells are isolated from the patients' Tumor tissue (or ascites) and peripheral blood obtained before standard chemotherapy and then cultured ex-vivo. The first infusion will be conducted in 7-10 days after chemotherapy and is assessed by the investigators.TIL-TCM cells are transfused to patients in a dosage escalated manner.The total dose was 1× 109-1 ×1010 cells.After cell infusion, IL-2 was administered at 720000 IU/kg (based on whole body weight) by intravenous (I.V.),every 8 hours for up to 4 days. Receives: Drug: Adoptive TIL-TCM transfer therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
Measured: Baseline up to 28 days after TIL-TCM cells infusion
Maximum Tolerated Dose（MTD）
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
Measured: Baseline up to 28 days after TIL-TCM cells infusion
incidence of adverse events( AE )and Serious adverse events(SAE)
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
Measured: up to 72 weeks after TIL-TCM cells infusion
Secondary outcomes (3)
Overall response rate (ORR)
ORR is defined as the percentage of patients who have a clinical response (objective tumor regression).ORR is computed by: the sum of the number of patients with Complete Response (CR) and number of patients with Partial Response (PR) / total number of patients. The total number of patients is the sum of the number of patients with CR, PR, stable disease (SD) or progressive disease (PD). The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) is used as the criteria to determine whether a tumor disappears (CR), shrinks (PR), stays the same (SD) or gets bigger (PD).
Measured: 18 months
Duration of response (DOR)
DOR is the time between the initial response to treatment per RECIST v1.1 and subsequent disease progression among patients achieving Complete Response (CR) or Partial Response (PR). RECIST v1.1 is used as the criteria to determine whether a tumor disappears (CR) or shrinks (PR).
Measured: 18 months
Progression-free survival (PFS)
PFS is the length of time from the date patient enrolled in to the date on which tumor progresses or the patient dies for any cause.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start2 Apr 2021
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sizhen Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Biomed-union Biotechnology Co., Ltd.
- Responsible party
- Sponsor-investigator, Sizhen Wang, Jinling Hospital, China
- Investigators
- Xinbo Wang, MD, Study director, Jinling Hospital,Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438797
- Sponsor's protocol ID
- 2022DZKY-039-02
- Status last verified
- Jun 2022
- First submitted
- 26 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Specific TIL-TCM Cells for Advanced Relapse-refractory or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05438797
- Acronym / sponsor ID
- 2022DZKY-039-02
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Sizhen WangUniversity, hospital or other
- Collaborators
- Shanghai Biomed-union Biotechnology Co., Ltd.
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 30 Jun 2022 (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.
Clinical Study on the Safety and Efficacy of specific TIL-TCM cells for advanced relapse-refractory or metastatic pancreatic cancer.
Detailed description
This is a single arm, open-label, single-center study.This study is indicated for advanced relapse-refractory or metastatic pancreatic cancer.The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. Primary objective is to explore the safety, main consideration is dose-related safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adoptive TIL-TCM transfer | Experimental | Drug: Adoptive TIL-TCM transfer therapyTIL-TCM cells are isolated from the patients' Tumor tissue (or ascites) and peripheral blood obtained before standard chemotherapy and then cultured ex-vivo. The first infusion will be conducted in 7-10 days after chemotherapy and is assessed by the investigators.TIL-TCM cells are transfused to patients in a dosage escalated manner.The total dose was 1× 109-1 ×1010 cells.After cell infusion, IL-2 was administered at 720000 IU/kg (based on whole body weight) by intravenous (I.V.),every 8 hours for up to 4 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged≥18 years old and ≤70 years old when signing the informed consent; regardless of gender;Body weight>40kg.
- Patients with advanced recurrent refractory or metastatic pancreatic cancer who have failed at least one standard treatment or who are unable to tolerate, unwilling or financially unable to receive standard treatment.
- The subject will have at least one eligible tissue or sample available for cell preparation.
- Patients with brain metastatic lesions who are asymptomatic , the diameter of a single lesion ≤1 cm, and the number of lesions ≤3 may be eligible.
- Patients should have good clinical presentation status (ECOG 0 or 1).
Key exclusion criteria (19 listed)
- Pregnancy or lactation;
- Active infections requiring systemic anti-infective therapy ( topical antibiotics excepted);
- Patients who are taking systemic steroids or immunosuppressive drugs;
- Hepatitis B (hepatitis B surface antigen [HbsAg] and/or core antibody [HbcAb] positive, HBV-DNA<1000 copies /mL can be included);
- Hepatitis C ( HCV antibody positive and HCV-RNA positive);
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 |
|---|---|---|
| Adoptive TIL-TCM transfer therapyAlso: TIL-TCMAbraxane:100-200 mg/m2，QD×1D;Cyclophosphamide:15-35 mg/kg/d，QD×2D. Biological: Adoptive TIL-TCM transfer therapy | Drug | adoptive TIL-TCM transfer |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after TIL-TCM cells infusion
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
Maximum Tolerated Dose（MTD）
Time frame: Baseline up to 28 days after TIL-TCM cells infusion
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
incidence of adverse events( AE )and Serious adverse events(SAE)
Time frame: up to 72 weeks after TIL-TCM cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
3 secondary outcomes
Overall response rate (ORR)
Time frame: 18 months
Duration of response (DOR)
Time frame: 18 months
Progression-free survival (PFS)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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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.
Xinbo Wang, MD study director
Jinling Hospital,Nanjing University
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 Adoptive TIL-TCM transfer therapy in people with Advanced Pancreatic Cancer, run by Sizhen Wang 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 19 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 30 Jun 2022. 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 Xinbo Wang, MD (13505172912, wxinbo2008@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: Baseline up to 28 days after TIL-TCM cells infusion). The study lists 3 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 30 Jun 2022.